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NCT03430011 · OUTCOME

Number of Participants With Clinically Significant Laboratory Abnormalities by Severity in Phase 2 and Phase 2a

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From the time of JCARH125 infusion to 90 days following the infusion (Up to 90 days)

What was measured

Clinically significant laboratory abnormalities are assessed by investigator and are reported as treatment-emergent adverse event (TEAE). TEAE is defined as an AE that starts any time from initiation of JCARH125 administration through and including 90 days following the JCARH125 infusion graded by Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Any AE occurring after the initiation of another anticancer treatment is not considered a TEAE. Grade 3=Severe; Grade 4=Life-threatening.

Analysis population: All participants who received at least one infusion of JCARH125 in phase 2 and in phase 2a

Groups in this outcome

Phase 2 600 x 10^6 Cells

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

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 2 600 x 10^6 Cells24
Phase 2a 600 x 10^6 Cells Anti-BCMA10

Reported measurements

Neutropenia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells3Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA1Not reportedNot reportedNot reportedNot reported
Neutropenia grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells18Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA6Not reportedNot reportedNot reportedNot reported
Anemia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells11Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA3Not reportedNot reportedNot reportedNot reported
Thrombocytopenia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells3Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA0Not reportedNot reportedNot reportedNot reported
Thrombocytopenia grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells10Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA3Not reportedNot reportedNot reportedNot reported
Leukopenia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA0Not reportedNot reportedNot reportedNot reported
Leukopenia grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells8Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA1Not reportedNot reportedNot reportedNot reported
Lymphopenia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA0Not reportedNot reportedNot reportedNot reported
Lymphopenia grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells3Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA0Not reportedNot reportedNot reportedNot reported
Febrile neutropenia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA0Not reportedNot reportedNot reportedNot reported
Hypophosphataemia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells6Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA1Not reportedNot reportedNot reportedNot reported
Hypocalcaemia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells3Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA0Not reportedNot reportedNot reportedNot reported
Hypocalcaemia grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA0Not reportedNot reportedNot reportedNot reported
Hypokalaemia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA0Not reportedNot reportedNot reportedNot reported
Hyponatraemia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA0Not reportedNot reportedNot reportedNot reported
Hyperglycaemia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA0Not reportedNot reportedNot reportedNot reported
Hypertriglyceridaemia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells3Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA0Not reportedNot reportedNot reportedNot reported
Lactic acidosis grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA0Not reportedNot reportedNot reportedNot reported
Alanine aminotransferase increased grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA0Not reportedNot reportedNot reportedNot reported
Aspartate aminotransferase increased grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA0Not reportedNot reportedNot reportedNot reported
Aspartate aminotransferase increased grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA0Not reportedNot reportedNot reportedNot reported
Blood fibrinogen decreased grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA0Not reportedNot reportedNot reportedNot reported
Blood fibrinogen decreased grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA0Not reportedNot reportedNot reportedNot reported
CD4 lymphocytes decreased grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
    title
    Neutropenia grade 3
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        6
    title
    Neutropenia grade 4
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        3
    title
    Anemia grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    Thrombocytopenia grade 3
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        3
    title
    Thrombocytopenia grade 4
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Leukopenia grade 3
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        1
    title
    Leukopenia grade 4
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Lymphopenia grade 3
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    Lymphopenia grade 4
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Febrile neutropenia grade 3
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        1
    title
    Hypophosphataemia grade 3
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    Hypocalcaemia grade 3
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    2. group Id
      OG001
      value
      10
    units
    Participants
description
Clinically significant laboratory abnormalities are assessed by investigator and are reported as treatment-emergent adverse event (TEAE). TEAE is defined as an AE that starts any time from initiation of JCARH125 administration through and including 90 days following the JCARH125 infusion graded by Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Any AE occurring after the initiation of another anticancer treatment is not considered a TEAE. Grade 3=Severe; Grade 4=Life-threatening.
groups
  1. description
    JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells expansion
    id
    OG000
    title
    Phase 2 600 x 10^6 Cells
  2. 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
    OG001
    title
    Phase 2a 600 x 10^6 Cells Anti-BCMA
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants who received at least one infusion of JCARH125 in phase 2 and in phase 2a
reporting Status
POSTED
time Frame
From the time of JCARH125 infusion to 90 days following the infusion (Up to 90 days)
title
Number of Participants With Clinically Significant Laboratory Abnormalities by Severity in Phase 2 and Phase 2a
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice