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NCT03548207 · OUTCOME

Phase 1b and Phase 2: Minimal Residual Disease (MRD) Negative Rate

A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2025-07-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Pre dose (Day 1) up to 45.2 months

What was measured

MRD negativity rate was defined as percentage of participants who had negative MRD by bone marrow aspirate at any timepoint after initial dose of JNJ-68284528 and before disease progression or starting subsequent therapy or retreatment with JNJ-68284528. MRD negativity rate was assessed by next-generation sequencing at a threshold of \<10\^5.

Analysis population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants with evaluable samples for MRD.

Groups in this outcome

Phase 1b (US Population)

Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\*10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\*10\^6 CAR-positive viable cells/kg) as IV infusion.

Phase 2 (US Population)

Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received recommended phase 2 dose (RP2D) dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.

Phase 2 (Japan Population)

Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.

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 1b (US Population)18
Phase 2 (US Population)39
Phase 2 (Japan Population)8

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1b (US Population)100.0Not reported81.5100.0Not reported
Phase 2 (US Population)89.7Not reported75.897.1Not reported
Phase 2 (Japan Population)75.0Not reported34.996.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        81.5
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG001
        lower Limit
        75.8
        upper Limit
        97.1
        value
        89.7
      3. group Id
        OG002
        lower Limit
        34.9
        upper Limit
        96.8
        value
        75.0
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    2. group Id
      OG001
      value
      39
    3. group Id
      OG002
      value
      8
    units
    Participants
description
MRD negativity rate was defined as percentage of participants who had negative MRD by bone marrow aspirate at any timepoint after initial dose of JNJ-68284528 and before disease progression or starting subsequent therapy or retreatment with JNJ-68284528. MRD negativity rate was assessed by next-generation sequencing at a threshold of \<10\^5.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\*10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\*10\^6 CAR-positive viable cells/kg) as IV infusion.
    id
    OG000
    title
    Phase 1b (US Population)
  2. description
    Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received recommended phase 2 dose (RP2D) dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
    id
    OG001
    title
    Phase 2 (US Population)
  3. description
    Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
    id
    OG002
    title
    Phase 2 (Japan Population)
param Type
NUMBER
population Description
mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants with evaluable samples for MRD.
reporting Status
POSTED
time Frame
Pre dose (Day 1) up to 45.2 months
title
Phase 1b and Phase 2: Minimal Residual Disease (MRD) Negative Rate
type
SECONDARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice