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NCT03430011 · OUTCOME

Number of Participants With Pharmacokinetics Persistence

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
Day 29, 60, 90, 180, 270, 365, 545, 730

What was measured

Pharmacokinetics persistence of JCARH125 CAR T cells in the blood as determined by quantitative polymerase chain reaction (qPCR) over time to detect the JCARH125 transgene. Persistence is defined as a transgene count greater than or equal to the lower limit of detection (LLOD).

Analysis population: All participants who have the necessary PK measurements to provide interpretable results for the specific parameters 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 Cells20
Phase 1 600 x 10^6 Cells17
Phase 1 Anakinra 600 x 10^6 Cells14
Phase 2 600 x 10^6 Cells23
Phase 2a 600 x 10^6 Cells Anti-BCMA10

Reported measurements

Day 29

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 Cells20
Phase 1 600 x 10^6 Cells17
Phase 1 Anakinra 600 x 10^6 Cells14
Phase 2 600 x 10^6 Cells23
Phase 2a 600 x 10^6 Cells Anti-BCMA10
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells14Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells29Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells26Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells20Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells17Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells14Not reportedNot reportedNot reportedNot reported
Phase 2 600 x 10^6 Cells23Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA10Not reportedNot reportedNot reportedNot reported
Day 60

Analysis denominator · Participants

GroupSource count
Phase 1 50 x 10^6 Cells12
Phase 1 150 x 10^6 Cells30
Phase 1 300 x 10^6 Cells25
Phase 1 450 x 10^6 Cells17
Phase 1 600 x 10^6 Cells13
Phase 1 Anakinra 600 x 10^6 Cells13
Phase 2 600 x 10^6 Cells22
Phase 2a 600 x 10^6 Cells Anti-BCMA10
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells9Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells26Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells21Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells16Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells13Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells12Not reportedNot reportedNot reportedNot reported
Phase 2 600 x 10^6 Cells21Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA10Not reportedNot reportedNot reportedNot reported
Day 90

Analysis denominator · Participants

GroupSource count
Phase 1 50 x 10^6 Cells13
Phase 1 150 x 10^6 Cells24
Phase 1 300 x 10^6 Cells24
Phase 1 450 x 10^6 Cells19
Phase 1 600 x 10^6 Cells11
Phase 1 Anakinra 600 x 10^6 Cells14
Phase 2 600 x 10^6 Cells21
Phase 2a 600 x 10^6 Cells Anti-BCMA8
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells5Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells16Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells20Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells17Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells9Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells13Not reportedNot reportedNot reportedNot reported
Phase 2 600 x 10^6 Cells18Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA7Not reportedNot reportedNot reportedNot reported
Day 180

Analysis denominator · Participants

GroupSource count
Phase 1 50 x 10^6 Cells9
Phase 1 150 x 10^6 Cells18
Phase 1 300 x 10^6 Cells21
Phase 1 450 x 10^6 Cells16
Phase 1 600 x 10^6 Cells13
Phase 1 Anakinra 600 x 10^6 Cells10
Phase 2 600 x 10^6 Cells18
Phase 2a 600 x 10^6 Cells Anti-BCMA7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells8Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells14Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells12Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells8Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells9Not reportedNot reportedNot reportedNot reported
Phase 2 600 x 10^6 Cells13Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA4Not reportedNot reportedNot reportedNot reported
Day 270

Analysis denominator · Participants

GroupSource count
Phase 1 50 x 10^6 Cells7
Phase 1 150 x 10^6 Cells9
Phase 1 300 x 10^6 Cells14
Phase 1 450 x 10^6 Cells8
Phase 1 600 x 10^6 Cells11
Phase 1 Anakinra 600 x 10^6 Cells10
Phase 2 600 x 10^6 Cells14
Phase 2a 600 x 10^6 Cells Anti-BCMA5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells9Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells9Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells7Not reportedNot reportedNot reportedNot reported
Phase 2 600 x 10^6 Cells8Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA4Not reportedNot reportedNot reportedNot reported
Day 365

Analysis denominator · Participants

GroupSource count
Phase 1 50 x 10^6 Cells7
Phase 1 150 x 10^6 Cells7
Phase 1 300 x 10^6 Cells7
Phase 1 450 x 10^6 Cells10
Phase 1 600 x 10^6 Cells12
Phase 1 Anakinra 600 x 10^6 Cells8
Phase 2 600 x 10^6 Cells14
Phase 2a 600 x 10^6 Cells Anti-BCMA5
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 Cells4Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells6Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells4Not reportedNot reportedNot reportedNot reported
Phase 2 600 x 10^6 Cells8Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA3Not reportedNot reportedNot reportedNot reported
Day 545

Analysis denominator · Participants

GroupSource count
Phase 1 50 x 10^6 Cells4
Phase 1 150 x 10^6 Cells2
Phase 1 300 x 10^6 Cells6
Phase 1 450 x 10^6 Cells6
Phase 1 600 x 10^6 Cells8
Phase 1 Anakinra 600 x 10^6 Cells3
Phase 2 600 x 10^6 Cells11
Phase 2a 600 x 10^6 Cells Anti-BCMA3
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 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells4Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells4Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells3Not reportedNot reportedNot reportedNot reported
Phase 2 600 x 10^6 Cells3Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA2Not reportedNot reportedNot reportedNot reported
Day 730

Analysis denominator · Participants

GroupSource count
Phase 1 50 x 10^6 Cells0
Phase 1 150 x 10^6 Cells2
Phase 1 300 x 10^6 Cells4
Phase 1 450 x 10^6 Cells3
Phase 1 600 x 10^6 Cells6
Phase 1 Anakinra 600 x 10^6 Cells3
Phase 2 600 x 10^6 Cells5
Phase 2a 600 x 10^6 Cells Anti-BCMA1
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 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells4Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 2 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 2a 600 x 10^6 Cells Anti-BCMA1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        29
      3. group Id
        OG002
        value
        26
      4. group Id
        OG003
        value
        20
      5. group Id
        OG004
        value
        17
      6. group Id
        OG005
        value
        14
      7. group Id
        OG006
        value
        23
      8. group Id
        OG007
        value
        10
    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
        20
      5. group Id
        OG004
        value
        17
      6. group Id
        OG005
        value
        14
      7. group Id
        OG006
        value
        23
      8. group Id
        OG007
        value
        10
      units
      Participants
    title
    Day 29
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        26
      3. group Id
        OG002
        value
        21
      4. group Id
        OG003
        value
        16
      5. group Id
        OG004
        value
        13
      6. group Id
        OG005
        value
        12
      7. group Id
        OG006
        value
        21
      8. group Id
        OG007
        value
        10
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        30
      3. group Id
        OG002
        value
        25
      4. group Id
        OG003
        value
        17
      5. group Id
        OG004
        value
        13
      6. group Id
        OG005
        value
        13
      7. group Id
        OG006
        value
        22
      8. group Id
        OG007
        value
        10
      units
      Participants
    title
    Day 60
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        16
      3. group Id
        OG002
        value
        20
      4. group Id
        OG003
        value
        17
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        13
      7. group Id
        OG006
        value
        18
      8. group Id
        OG007
        value
        7
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        24
      3. group Id
        OG002
        value
        24
      4. group Id
        OG003
        value
        19
      5. group Id
        OG004
        value
        11
      6. group Id
        OG005
        value
        14
      7. group Id
        OG006
        value
        21
      8. group Id
        OG007
        value
        8
      units
      Participants
    title
    Day 90
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        14
      4. group Id
        OG003
        value
        12
      5. group Id
        OG004
        value
        8
      6. group Id
        OG005
        value
        9
      7. group Id
        OG006
        value
        13
      8. group Id
        OG007
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        18
      3. group Id
        OG002
        value
        21
      4. group Id
        OG003
        value
        16
      5. group Id
        OG004
        value
        13
      6. group Id
        OG005
        value
        10
      7. group Id
        OG006
        value
        18
      8. group Id
        OG007
        value
        7
      units
      Participants
    title
    Day 180
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        7
      7. group Id
        OG006
        value
        8
      8. group Id
        OG007
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        14
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        11
      6. group Id
        OG005
        value
        10
      7. group Id
        OG006
        value
        14
      8. group Id
        OG007
        value
        5
      units
      Participants
    title
    Day 270
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        6
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        8
      8. group Id
        OG007
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        10
      5. group Id
        OG004
        value
        12
      6. group Id
        OG005
        value
        8
      7. group Id
        OG006
        value
        14
      8. group Id
        OG007
        value
        5
      units
      Participants
    title
    Day 365
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        3
      8. group Id
        OG007
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        8
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        11
      8. group Id
        OG007
        value
        3
      units
      Participants
    title
    Day 545
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        6
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        5
      8. group Id
        OG007
        value
        1
      units
      Participants
    title
    Day 730
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
      20
    5. group Id
      OG004
      value
      17
    6. group Id
      OG005
      value
      14
    7. group Id
      OG006
      value
      23
    8. group Id
      OG007
      value
      10
    units
    Participants
description
Pharmacokinetics persistence of JCARH125 CAR T cells in the blood as determined by quantitative polymerase chain reaction (qPCR) over time to detect the JCARH125 transgene. Persistence is defined as a transgene count greater than or equal to the lower limit of detection (LLOD).
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
COUNT_OF_PARTICIPANTS
population Description
All participants who have the necessary PK measurements to provide interpretable results for the specific parameters of interest
reporting Status
POSTED
time Frame
Day 29, 60, 90, 180, 270, 365, 545, 730
title
Number of Participants With Pharmacokinetics Persistence
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice