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NCT03430011 · OUTCOME

Number of Participants With Dose-Limiting Toxicity (DLT) in Phase 1

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 day 1 to day 22 following JCARH125 infusion (Up to 21 days)

What was measured

DLT is defined as adverse events (AEs) that occur within 21 days following JCARH125 infusion and meet any of the following criteria: * Treatment-emergent Grade ≥3 allergic reactions related to JCARH125; * Treatment-emergent Grade 3 seizures, regardless of attribution, that do not resolve to Grade ≤2 within 3 days in participants who have no evidence of central nervous system (CNS) involvement of Multiple Myeloma or other CNS pathology; * Treatment-emergent autoimmune toxicity Grade ≥3, regardless of attribution (excluding B-cell aplasia); * Treatment-emergent Grade 3 CRS that does not resolve to Grade ≤2 within 72 hours; * Any other treatment-emergent Grade 3 AE related to JCARH125 that does not resolve to Grade ≤2 within 7 days; * Any treatment-emergent Grade 4 AE related to JCARH125 that does not resolve to Grade ≤2 within 7 days; * Treatment-emergent Grade 4 Cytokine Release Syndrome of any duration; * Any treatment-emergent Grade 5 toxicity not due to the underlying malignancy

Analysis population: All participants who have either experienced a DLT or were followed for the full DLT evaluation period in phase 1

Groups in this outcome

Phase 1 50 x 10^6 Cells

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

Phase 1 150 x 10^6 Cells

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

Phase 1 300 x 10^6 Cells

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

Phase 1 450 x 10^6 Cells

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

Phase 1 600 x 10^6 Cells

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

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 1 50 x 10^6 Cells15
Phase 1 150 x 10^6 Cells30
Phase 1 300 x 10^6 Cells27
Phase 1 450 x 10^6 Cells22
Phase 1 600 x 10^6 Cells22

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells3Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      30
    3. group Id
      OG002
      value
      27
    4. group Id
      OG003
      value
      22
    5. group Id
      OG004
      value
      22
    units
    Participants
description
DLT is defined as adverse events (AEs) that occur within 21 days following JCARH125 infusion and meet any of the following criteria: * Treatment-emergent Grade ≥3 allergic reactions related to JCARH125; * Treatment-emergent Grade 3 seizures, regardless of attribution, that do not resolve to Grade ≤2 within 3 days in participants who have no evidence of central nervous system (CNS) involvement of Multiple Myeloma or other CNS pathology; * Treatment-emergent autoimmune toxicity Grade ≥3, regardless of attribution (excluding B-cell aplasia); * Treatment-emergent Grade 3 CRS that does not resolve to Grade ≤2 within 72 hours; * Any other treatment-emergent Grade 3 AE related to JCARH125 that does not resolve to Grade ≤2 within 7 days; * Any treatment-emergent Grade 4 AE related to JCARH125 that does not resolve to Grade ≤2 within 7 days; * Treatment-emergent Grade 4 Cytokine Release Syndrome of any duration; * Any treatment-emergent Grade 5 toxicity not due to the underlying malignancy
groups
  1. description
    JCARH125 IV at dose level 50 x 10\^6 consisting of CD3+CAR+T cells
    id
    OG000
    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
    OG001
    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
    OG002
    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
    OG003
    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
    OG004
    title
    Phase 1 600 x 10^6 Cells
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants who have either experienced a DLT or were followed for the full DLT evaluation period in phase 1
reporting Status
POSTED
time Frame
From day 1 to day 22 following JCARH125 infusion (Up to 21 days)
title
Number of Participants With Dose-Limiting Toxicity (DLT) in Phase 1
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice