NCT03548207 · OUTCOME

Phase 1b and Phase 2: Percentage of Participants With Positive Antibodies to 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: NUMBER
Unit: Percentage of participants
Interval / dispersion: Not reported
Time frame: Pre dose (Day 1) up to 2 years

What was measured

Percentage of participants with positive antibodies to JNJ-68284528 were reported.

Analysis population: All treated analysis set included all participants who received JNJ-68284528 infusion.

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

Group	Source count
Phase 1b (US Population)	29
Phase 2 (US Population)	68
Phase 2 (Japan Population)	9

Reported measurements

Source class 1

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1b (US Population)	48.3	Not reported	Not reported	Not reported	Not reported
Phase 2 (US Population)	35.3	Not reported	Not reported	Not reported	Not reported
Phase 2 (Japan Population)	44.4	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
48.3
group Id
OG001
value
35.3
group Id
OG002
value
44.4

denoms

counts
group Id
OG000
value
29
group Id
OG001
value
68
group Id
OG002
value
9
units
Participants

description

Percentage of participants with positive antibodies to JNJ-68284528 were reported.

groups

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)
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)
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

All treated analysis set included all participants who received JNJ-68284528 infusion.

reporting Status

POSTED

time Frame

Pre dose (Day 1) up to 2 years

title

Phase 1b and Phase 2: Percentage of Participants With Positive Antibodies to JNJ-68284528

type

SECONDARY

unit Of Measure

Percentage of participants

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

Preserved source evidence · Not medical advice