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NCT03548207 · OUTCOME

Phase 1b and Phase 2: Mean Concentration of Soluble B-cell Maturation Antigen (BCMA) Levels in Serum After Single Infusion of JNJ-68284528

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
MEAN
Unit
Micrograms per liter (mcg/L)
Interval / dispersion
Full Range
Time frame
Days 352 and 1024

What was measured

Mean concentration of soluble BCMA levels in serum after single infusion of JNJ-68284528 were reported.

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 who were evaluable for this outcome measure. Zero (0) participants in the number analyzed field for arm "Phase 2 (Japan Population)" at Day 1024 signifies that no participants were available for the analysis because no sBCMA samples were collected and analyzed due to change in planned analysis.

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)11
Phase 2 (US Population)33
Phase 2 (Japan Population)8

Reported measurements

Day 352

Analysis denominator · Participants

GroupSource count
Phase 1b (US Population)11
Phase 2 (US Population)33
Phase 2 (Japan Population)8
Values in Micrograms per liter (mcg/L) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1b (US Population)2.25Not reportedNA7.65Here, "NA" signifies that lower limit of full range could not be estimated as it was below the quantification limit.
Phase 2 (US Population)2.01Not reportedNA10.40Here, "NA" signifies that lower limit of full range could not be estimated as it was below the quantification limit.
Phase 2 (Japan Population)5.61Not reportedNA23.0Here, "NA" signifies that lower limit of full range could not be estimated as it was below the quantification limit.
Day 1024

Analysis denominator · Participants

GroupSource count
Phase 1b (US Population)11
Phase 2 (US Population)33
Phase 2 (Japan Population)0
Values in Micrograms per liter (mcg/L) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1b (US Population)6.70Not reported0.3114.7Not reported
Phase 2 (US Population)7.05Not reported3.2111.90Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Here, "NA" signifies that lower limit of full range could not be estimated as it was below the quantification limit.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        7.65
        value
        2.25
      2. comment
        Here, "NA" signifies that lower limit of full range could not be estimated as it was below the quantification limit.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        10.40
        value
        2.01
      3. comment
        Here, "NA" signifies that lower limit of full range could not be estimated as it was below the quantification limit.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        23.0
        value
        5.61
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        33
      3. group Id
        OG002
        value
        8
      units
      Participants
    title
    Day 352
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.31
        upper Limit
        14.7
        value
        6.70
      2. group Id
        OG001
        lower Limit
        3.21
        upper Limit
        11.90
        value
        7.05
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        33
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Day 1024
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      33
    3. group Id
      OG002
      value
      8
    units
    Participants
description
Mean concentration of soluble BCMA levels in serum after single infusion of JNJ-68284528 were reported.
dispersion Type
Full Range
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
MEAN
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 who were evaluable for this outcome measure. Zero (0) participants in the number analyzed field for arm "Phase 2 (Japan Population)" at Day 1024 signifies that no participants were available for the analysis because no sBCMA samples were collected and analyzed due to change in planned analysis.
reporting Status
POSTED
time Frame
Days 352 and 1024
title
Phase 1b and Phase 2: Mean Concentration of Soluble B-cell Maturation Antigen (BCMA) Levels in Serum After Single Infusion of JNJ-68284528
type
SECONDARY
unit Of Measure
Micrograms per liter (mcg/L)

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Preserved source evidence · Not medical advice