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NCT03430011 · OUTCOME

Maximum Observed Concentration (Cmax)

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
GEOMETRIC_MEAN
Unit
Copies/UG
Interval / dispersion
Geometric Coefficient of Variation
Time frame
From JCARH125 infusion through the day 29 visit

What was measured

Cmax is the maximal concentration of JCARH125 CAR T cells in the blood after its infusion as determined by quantitative polymerase chain reaction (qPCR) to detect the JCARH125 transgene.

Analysis population: All participants who have the necessary PK measurements to provide interpretable results for this specific parameter of interest

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

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

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 1 50 x 10^6 Cells14
Phase 1 150 x 10^6 Cells30
Phase 1 300 x 10^6 Cells26
Phase 1 450 x 10^6 Cells21
Phase 1 600 x 10^6 Cells20
Phase 1 Anakinra 600 x 10^6 Cells14
Phase 2 600 x 10^6 Cells24
Phase 2a 600 x 10^6 Cells Anti-BCMA10

Reported measurements

Source class 1
Values in Copies/UG · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells61037.57365.26Not reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells64705.82305.31Not reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells123460.33156.23Not reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells122228.99174.22Not reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells162706.0083.19Not reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells176233.6499.44Not reportedNot reportedNot reported
Phase 2 600 x 10^6 Cells140331.08234.07Not reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA103009.98128.25Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        365.26
        value
        61037.57
      2. group Id
        OG001
        spread
        305.31
        value
        64705.82
      3. group Id
        OG002
        spread
        156.23
        value
        123460.33
      4. group Id
        OG003
        spread
        174.22
        value
        122228.99
      5. group Id
        OG004
        spread
        83.19
        value
        162706.00
      6. group Id
        OG005
        spread
        99.44
        value
        176233.64
      7. group Id
        OG006
        spread
        234.07
        value
        140331.08
      8. group Id
        OG007
        spread
        128.25
        value
        103009.98
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      30
    3. group Id
      OG002
      value
      26
    4. group Id
      OG003
      value
      21
    5. group Id
      OG004
      value
      20
    6. group Id
      OG005
      value
      14
    7. group Id
      OG006
      value
      24
    8. group Id
      OG007
      value
      10
    units
    Participants
description
Cmax is the maximal concentration of JCARH125 CAR T cells in the blood after its infusion as determined by quantitative polymerase chain reaction (qPCR) to detect the JCARH125 transgene.
dispersion Type
Geometric Coefficient of Variation
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
  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
    OG005
    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
    OG006
    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
    OG007
    title
    Phase 2a 600 x 10^6 Cells Anti-BCMA
param Type
GEOMETRIC_MEAN
population Description
All participants who have the necessary PK measurements to provide interpretable results for this specific parameter of interest
reporting Status
POSTED
time Frame
From JCARH125 infusion through the day 29 visit
title
Maximum Observed Concentration (Cmax)
type
SECONDARY
unit Of Measure
Copies/UG

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

Preserved source evidence · Not medical advice