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NCT03430011 · ADVERSE EVENTS

Adverse events

Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2024-05-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until their study completion (up to approximately 61 months). SAEs and other AEs were assessed from first JCARH125 infusion until 90 days following the JCARH125 infusion (up to approximately 41 months).
Other-event reporting threshold
5%

The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 infusion of study medication (JCARH125).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1 50 x 10^6 Cells

JCARH125 IV at dose level 50 x 10\^6 consisting of CD3+CAR+T cells

1 / 1414 / 145 / 15
Phase 1 150 x 10^6 Cells

JCARH125 IV at dose level 150 x 10\^6 consisting of CD3+CAR+T cells

14 / 3030 / 3022 / 30
Phase 1 300 x 10^6 Cells

JCARH125 IV at dose level 300 x 10\^6 consisting of CD3+CAR+T cells

7 / 2626 / 2614 / 27
Phase 1 450 x 10^6 Cells

JCARH125 IV at dose level 450 x 10\^6 consisting of CD3+CAR+T cells

7 / 2121 / 219 / 22
Phase 1 600 x 10^6 Cells

JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells

7 / 2020 / 207 / 22
Phase 1 Anakinra 600 x 10^6 Cells

2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells

5 / 1414 / 144 / 14
Phase 2 600 x 10^6 Cells

JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells expansion

11 / 2424 / 246 / 25
Phase 2a 600 x 10^6 Cells Anti-BCMA

JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy

1 / 1010 / 102 / 10

Group identifiers: EG000: Phase 1 50 x 10^6 Cells · EG001: Phase 1 150 x 10^6 Cells · EG002: Phase 1 300 x 10^6 Cells · EG003: Phase 1 450 x 10^6 Cells · EG004: Phase 1 600 x 10^6 Cells · EG005: Phase 1 Anakinra 600 x 10^6 Cells · EG006: Phase 2 600 x 10^6 Cells · EG007: Phase 2a 600 x 10^6 Cells Anti-BCMA

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Left ventricular dysfunction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Pericardial effusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Pericarditis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Large intestinal obstruction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Large intestine perforation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    General physical health deterioration

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      15
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      11
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      18
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      10
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Coagulopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      20
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      11
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      21
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      10
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      19
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      10
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      10
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Ventricular tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Hypoacusis
Complete source fields
description
The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 infusion of study medication (JCARH125).
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    15
    description
    JCARH125 IV at dose level 50 x 10\^6 consisting of CD3+CAR+T cells
    id
    EG000
    other Num Affected
    14
    other Num At Risk
    14
    serious Num Affected
    1
    serious Num At Risk
    14
    title
    Phase 1 50 x 10^6 Cells
  2. deaths Num Affected
    22
    deaths Num At Risk
    30
    description
    JCARH125 IV at dose level 150 x 10\^6 consisting of CD3+CAR+T cells
    id
    EG001
    other Num Affected
    30
    other Num At Risk
    30
    serious Num Affected
    14
    serious Num At Risk
    30
    title
    Phase 1 150 x 10^6 Cells
  3. deaths Num Affected
    14
    deaths Num At Risk
    27
    description
    JCARH125 IV at dose level 300 x 10\^6 consisting of CD3+CAR+T cells
    id
    EG002
    other Num Affected
    26
    other Num At Risk
    26
    serious Num Affected
    7
    serious Num At Risk
    26
    title
    Phase 1 300 x 10^6 Cells
  4. deaths Num Affected
    9
    deaths Num At Risk
    22
    description
    JCARH125 IV at dose level 450 x 10\^6 consisting of CD3+CAR+T cells
    id
    EG003
    other Num Affected
    21
    other Num At Risk
    21
    serious Num Affected
    7
    serious Num At Risk
    21
    title
    Phase 1 450 x 10^6 Cells
  5. deaths Num Affected
    7
    deaths Num At Risk
    22
    description
    JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells
    id
    EG004
    other Num Affected
    20
    other Num At Risk
    20
    serious Num Affected
    7
    serious Num At Risk
    20
    title
    Phase 1 600 x 10^6 Cells
  6. deaths Num Affected
    4
    deaths Num At Risk
    14
    description
    2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells
    id
    EG005
    other Num Affected
    14
    other Num At Risk
    14
    serious Num Affected
    5
    serious Num At Risk
    14
    title
    Phase 1 Anakinra 600 x 10^6 Cells
  7. deaths Num Affected
    6
    deaths Num At Risk
    25
    description
    JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells expansion
    id
    EG006
    other Num Affected
    24
    other Num At Risk
    24
    serious Num Affected
    11
    serious Num At Risk
    24
    title
    Phase 2 600 x 10^6 Cells
  8. deaths Num Affected
    2
    deaths Num At Risk
    10
    description
    JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
    id
    EG007
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    1
    serious Num At Risk
    10
    title
    Phase 2a 600 x 10^6 Cells Anti-BCMA
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      15
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      11
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      18
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      10
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Coagulopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      20
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      11
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      21
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      10
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      19
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      10
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      10
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Ventricular tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Hypoacusis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Left ventricular dysfunction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Pericardial effusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Pericarditis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Large intestinal obstruction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    Large intestine perforation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    term
    General physical health deterioration
time Frame
Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until their study completion (up to approximately 61 months). SAEs and other AEs were assessed from first JCARH125 infusion until 90 days following the JCARH125 infusion (up to approximately 41 months).

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Preserved source evidence · Not medical advice