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NCT03430011 · FLOW

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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.

groups
  1. description
    JCARH125 IV at dose level 50 x 10\^6 consisting of CD3+CAR+T cells
    id
    FG000
    title
    Phase 1 50 x 10^6 Cells
  2. description
    JCARH125 IV at dose level 150 x 10\^6 consisting of CD3+CAR+T cells
    id
    FG001
    title
    Phase 1 150 x 10^6 Cells
  3. description
    JCARH125 IV at dose level 300 x 10\^6 consisting of CD3+CAR+T cells
    id
    FG002
    title
    Phase 1 300 x 10^6 Cells
  4. description
    JCARH125 IV at dose level 450 x 10\^6 consisting of CD3+CAR+T cells
    id
    FG003
    title
    Phase 1 450 x 10^6 Cells
  5. description
    JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells
    id
    FG004
    title
    Phase 1 600 x 10^6 Cells
  6. 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
    FG005
    title
    Phase 1 Anakinra 600 x 10^6 Cells
  7. description
    JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells expansion
    id
    FG006
    title
    Phase 2 600 x 10^6 Cells
  8. 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
    FG007
    title
    Phase 2a 600 x 10^6 Cells Anti-BCMA
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Screen Fail
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      No JCARH125 - disease related complications
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Participant not eligible - other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        27
      4. group Id
        FG003
        num Subjects
        22
      5. group Id
        FG004
        num Subjects
        22
      6. group Id
        FG005
        num Subjects
        14
      7. group Id
        FG006
        num Subjects
        25
      8. group Id
        FG007
        num Subjects
        10
      comment
      Underwent Leukapheresis
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        26
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        20
      6. group Id
        FG005
        num Subjects
        14
      7. group Id
        FG006
        num Subjects
        24
      8. group Id
        FG007
        num Subjects
        10
      type
      Received Lymphodepleting Chemotherapy (LDC)
    3. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        26
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        20
      6. group Id
        FG005
        num Subjects
        14
      7. group Id
        FG006
        num Subjects
        24
      8. group Id
        FG007
        num Subjects
        10
      comment
      Received JCARH125
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Pre-Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        3
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        2
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        2
      type
      Other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        26
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        20
      6. group Id
        FG005
        num Subjects
        14
      7. group Id
        FG006
        num Subjects
        24
      8. group Id
        FG007
        num Subjects
        10
      comment
      Received JCARH125
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        11
      8. group Id
        FG007
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        21
      3. group Id
        FG002
        num Subjects
        19
      4. group Id
        FG003
        num Subjects
        15
      5. group Id
        FG004
        num Subjects
        11
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        13
      8. group Id
        FG007
        num Subjects
        7
      type
      NOT COMPLETED
    title
    JCARH125 Treatment
Complete source fields
groups
  1. description
    JCARH125 IV at dose level 50 x 10\^6 consisting of CD3+CAR+T cells
    id
    FG000
    title
    Phase 1 50 x 10^6 Cells
  2. description
    JCARH125 IV at dose level 150 x 10\^6 consisting of CD3+CAR+T cells
    id
    FG001
    title
    Phase 1 150 x 10^6 Cells
  3. description
    JCARH125 IV at dose level 300 x 10\^6 consisting of CD3+CAR+T cells
    id
    FG002
    title
    Phase 1 300 x 10^6 Cells
  4. description
    JCARH125 IV at dose level 450 x 10\^6 consisting of CD3+CAR+T cells
    id
    FG003
    title
    Phase 1 450 x 10^6 Cells
  5. description
    JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells
    id
    FG004
    title
    Phase 1 600 x 10^6 Cells
  6. 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
    FG005
    title
    Phase 1 Anakinra 600 x 10^6 Cells
  7. description
    JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells expansion
    id
    FG006
    title
    Phase 2 600 x 10^6 Cells
  8. 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
    FG007
    title
    Phase 2a 600 x 10^6 Cells Anti-BCMA
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Screen Fail
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      No JCARH125 - disease related complications
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Participant not eligible - other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        27
      4. group Id
        FG003
        num Subjects
        22
      5. group Id
        FG004
        num Subjects
        22
      6. group Id
        FG005
        num Subjects
        14
      7. group Id
        FG006
        num Subjects
        25
      8. group Id
        FG007
        num Subjects
        10
      comment
      Underwent Leukapheresis
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        26
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        20
      6. group Id
        FG005
        num Subjects
        14
      7. group Id
        FG006
        num Subjects
        24
      8. group Id
        FG007
        num Subjects
        10
      type
      Received Lymphodepleting Chemotherapy (LDC)
    3. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        26
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        20
      6. group Id
        FG005
        num Subjects
        14
      7. group Id
        FG006
        num Subjects
        24
      8. group Id
        FG007
        num Subjects
        10
      comment
      Received JCARH125
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Pre-Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        3
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        2
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        2
      type
      Other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        26
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        20
      6. group Id
        FG005
        num Subjects
        14
      7. group Id
        FG006
        num Subjects
        24
      8. group Id
        FG007
        num Subjects
        10
      comment
      Received JCARH125
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        11
      8. group Id
        FG007
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        21
      3. group Id
        FG002
        num Subjects
        19
      4. group Id
        FG003
        num Subjects
        15
      5. group Id
        FG004
        num Subjects
        11
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        13
      8. group Id
        FG007
        num Subjects
        7
      type
      NOT COMPLETED
    title
    JCARH125 Treatment

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