68284528MMY2003 (CARTITUDE-2)

A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Multiple Myeloma 

Study treatments

After lymphodepletion, JNJ-68284528 will be administered as a single infusion to participants

•  in cohort A (Progressive disease after 1-3 prior lines of therapy)
• cohort B (Early relapse after front-line)
• cohort C (Relapsed/refractory multiple myeloma after proteasome inhibitor [PI], immunomodulatory [IMiD], anti-CD38, and anti-B-cell maturation antigen [BCMA] therapy) 
• cohort D (Less than CR after autologous stem cell transplantation [ASCT] front-line therapy; some participants will be administered JNJ-68284528 followed by lenalidomide). 
• Participants in cohort E (Newly diagnosed multiple myeloma, transplant not planned, high risk disease) will first be administered with quadruplet induction regimen of daratumumab, bortezomib, lenalidomide and dexamethasone (D-VRd), followed by lymphodepletion and JNJ-68284528, followed by a consolidation regimen of daratumumab and lenalidomide (D+R).

Inclusion criteria

• Cohort B: Received one line of prior therapy including a PI and an IMiD, and disease progression per IMWG criteria less than or equal to (<=) 12 months after treatment with autologous stem cell transplantation (ASCT) or <=12 months from the start of anti-myeloma therapy for participants who have not had an ASCT
• Cohort C: Previously treated with a PI, an IMiD, an anti-CD38 monoclonal antibody and B-cell maturation antigen (BCMA)-directed therapy
• Cohort D: Newly diagnosed multiple myeloma per IMWG with a history of 4 to 8 total cycles of initial therapy, including induction, high-dose therapy, and ASCT with or without consolidation
• Cohort E: Have newly diagnosed multiple myeloma without prior therapy and classified as high risk per International Staging System (ISS) stage III criteria, defined as: beta 2 microglobulin greater than (>) 5.5 milligram per litre (mg/L)

Cohort A, B, C, E:

• Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) or urine M-protein level >=200 milligram (mg)/24 hours
• Light chain multiple myeloma in whom only measurable disease is by serum free light chain (FLC) levels in the serum: Serum immunoglobulin FLC >=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
• Cohort A, B, C: For participants with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria
• Cohort A, B, C, D, E: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1

Exclusion criteria

Cohort A, B, D: Any therapy that is targeted to BCMA

Cohort A, B, C, D:

• Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target
• Ongoing toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
• Received a cumulative dose of corticosteroids equivalent to >=70 mg of prednisone within the 7 days (Cohort A, B, C) or 14 days (Cohort D) prior to apheresis

Participating sites

• University Hospital Leuven Gasthuisberg