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NCT03430011 · OUTCOME

Complete Response Rate (CRR)

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
NUMBER
Unit
Percent of participants
Interval / dispersion
95% Confidence Interval
Time frame
From the time of the JCARH125 infusion until disease progression, end of study, or the start of another anticancer therapy or stem cell transplant (Up to aproximately 61 months)

What was measured

CRR is defined as stringent complete response (sCR) or complete response (CR), according to IMWG criteria. Participants without any reported disease response assessments will be considered non-responders. sCR=complete response plus normal free light chain ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow aspirates

Analysis population: All participants who received conforming JCARH125 cell product at the recommended phase 2 dose (and at least one dose of anakinra as prophylactic intervention for phase 1 Anakinra) and have measurable disease at the last disease assessment prior to receiving JCARH125 infusion

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 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 Percent of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells42.9Not reported17.771.1Not reported
Phase 1 150 x 10^6 Cells33.3Not reported17.352.8Not reported
Phase 1 300 x 10^6 Cells46.2Not reported26.666.6Not reported
Phase 1 450 x 10^6 Cells45.0Not reported23.168.5Not reported
Phase 1 600 x 10^6 Cells65.0Not reported40.884.6Not reported
Phase 1 Anakinra 600 x 10^6 Cells35.7Not reported12.864.9Not reported
Phase 2 600 x 10^6 Cells54.2Not reported32.874.4Not reported
Phase 2a 600 x 10^6 Cells Anti-BCMA40.0Not reported12.273.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.7
        upper Limit
        71.1
        value
        42.9
      2. group Id
        OG001
        lower Limit
        17.3
        upper Limit
        52.8
        value
        33.3
      3. group Id
        OG002
        lower Limit
        26.6
        upper Limit
        66.6
        value
        46.2
      4. group Id
        OG003
        lower Limit
        23.1
        upper Limit
        68.5
        value
        45.0
      5. group Id
        OG004
        lower Limit
        40.8
        upper Limit
        84.6
        value
        65.0
      6. group Id
        OG005
        lower Limit
        12.8
        upper Limit
        64.9
        value
        35.7
      7. group Id
        OG006
        lower Limit
        32.8
        upper Limit
        74.4
        value
        54.2
      8. group Id
        OG007
        lower Limit
        12.2
        upper Limit
        73.8
        value
        40.0
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
      20
    6. group Id
      OG005
      value
      14
    7. group Id
      OG006
      value
      24
    8. group Id
      OG007
      value
      10
    units
    Participants
description
CRR is defined as stringent complete response (sCR) or complete response (CR), according to IMWG criteria. Participants without any reported disease response assessments will be considered non-responders. sCR=complete response plus normal free light chain ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow aspirates
dispersion Type
95% Confidence Interval
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
NUMBER
population Description
All participants who received conforming JCARH125 cell product at the recommended phase 2 dose (and at least one dose of anakinra as prophylactic intervention for phase 1 Anakinra) and have measurable disease at the last disease assessment prior to receiving JCARH125 infusion
reporting Status
POSTED
time Frame
From the time of the JCARH125 infusion until disease progression, end of study, or the start of another anticancer therapy or stem cell transplant (Up to aproximately 61 months)
title
Complete Response Rate (CRR)
type
SECONDARY
unit Of Measure
Percent of participants

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

Preserved source evidence · Not medical advice