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NCT03430011 · OUTCOME

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity in Phase 1 and Phase 1 Anakinra

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

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 using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Any AE occurring after the initiation of another anticancer treatment will not be considered a TEAE. Grade 3=Severe; Grade 4=Life-threatening; and Grade 5=death.

Analysis population: All participants who received at least one infusion of JCARH125 (and at least one dose of anakinra as prophylactic intervention for phase 1 Anakinra) in phase 1 and in phase 1 Anakinra

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

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

Reported measurements

TEAE
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 Cells30Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells26Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells21Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells20Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells14Not reportedNot reportedNot reportedNot reported
Grade 3-5 TEAE
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 Cells30Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells25Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells21Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells20Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells13Not reportedNot reportedNot reportedNot reported
Grade 5 TEAE
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 Cells2Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
JCARH125-Related TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells12Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells26Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells25Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells21Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells20Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells14Not reportedNot reportedNot reportedNot reported
JCARH125-Related Grade 3-5 TEAE
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 Cells10Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells15Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells16Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells16Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells7Not reportedNot reportedNot reportedNot reported
JCARH125-Related Grade 5 TEAE
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 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      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
    title
    TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        30
      3. group Id
        OG002
        value
        25
      4. group Id
        OG003
        value
        21
      5. group Id
        OG004
        value
        20
      6. group Id
        OG005
        value
        13
    title
    Grade 3-5 TEAE
  3. 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
        2
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Grade 5 TEAE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        26
      3. group Id
        OG002
        value
        25
      4. group Id
        OG003
        value
        21
      5. group Id
        OG004
        value
        20
      6. group Id
        OG005
        value
        14
    title
    JCARH125-Related TEAE
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        15
      4. group Id
        OG003
        value
        16
      5. group Id
        OG004
        value
        16
      6. group Id
        OG005
        value
        7
    title
    JCARH125-Related Grade 3-5 TEAE
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    JCARH125-Related Grade 5 TEAE
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
    units
    Participants
description
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 using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Any AE occurring after the initiation of another anticancer treatment will not be considered a TEAE. Grade 3=Severe; Grade 4=Life-threatening; and Grade 5=death.
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
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants who received at least one infusion of JCARH125 (and at least one dose of anakinra as prophylactic intervention for phase 1 Anakinra) in phase 1 and in phase 1 Anakinra
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 Treatment-Emergent Adverse Events (TEAEs) by Severity in Phase 1 and Phase 1 Anakinra
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice