Participant flow

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.

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

   FG000

   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

   FG001

   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

   FG002

   title

   Phase 2 (Japan Population)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         23

      3. group Id

         FG002

         num Subjects

         3

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         0

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         40

      3. group Id

         FG002

         num Subjects

         6

      type

      Sponsor decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         10

      3. group Id

         FG002

         num Subjects

         4

      type

      Randomized but not treated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         35

      2. group Id

         FG001

         num Subjects

         78

      3. group Id

         FG002

         num Subjects

         13

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         29

      2. group Id

         FG001

         num Subjects

         68

      3. group Id

         FG002

         num Subjects

         9

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         35

      2. group Id

         FG001

         num Subjects

         78

      3. group Id

         FG002

         num Subjects

         13

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

As planned, data for Phase 2 participants were reported separately for US population (78 participants) and Japan population (13 participants).

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Preserved source evidence · Not medical advice