NCT03548207 · OUTCOME

Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinite Time (AUC0-infinity) of CD3+CAR+ Cells in Blood After a 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: Days*cells per microliter
Interval / dispersion: Standard Deviation
Time frame: Pre and post dose on Day 1 and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years)

What was measured

Area under the plasma concentration versus time curve from time 0 to infinite time of CD3+CAR+ Cells in blood after a single infusion of JNJ-68284528 was 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.

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

Reported measurements

Source class 1

Values in Days*cells per microliter · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 1b (US Population)	10937	8658	Not reported	Not reported	Not reported
Phase 2 (US Population)	31966	58976	Not reported	Not reported	Not reported
Phase 2 (Japan Population)	7144.5	5905	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
8658
value
10937
group Id
OG001
spread
58976
value
31966
group Id
OG002
spread
5905
value
7144.5

denoms

counts
group Id
OG000
value
11
group Id
OG001
value
33
group Id
OG002
value
2
units
Participants

description

Area under the plasma concentration versus time curve from time 0 to infinite time of CD3+CAR+ Cells in blood after a single infusion of JNJ-68284528 was reported.

dispersion Type

Standard Deviation

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

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.

reporting Status

POSTED

time Frame

Pre and post dose on Day 1 and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years)

title

Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinite Time (AUC0-infinity) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528

type

SECONDARY

unit Of Measure

Days*cells per microliter

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

Preserved source evidence · Not medical advice