Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-68284528 · 2 trials · 1 indication
MRD negative rate is the percentage of participants who achieve MRD negative status by evaluation of bone marrow aspirate as defined by the International Myeloma Working Group (IMWG) criteria.
Sustained MRD-negative CR is defined as participants with CR or better who sustain MRD-negative status, as determined by next-generation sequencing (NGS) or next generation flowcytometry (NGF) with sensitivity of 10\^-5, for at least 12 months without any examination showing MRD positive status or progressive disease in between.
An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
ORR was defined as the percentage of participants who achieved partial response (PR) or better according to international myeloma working group (IMWG) criteria. IMWG criteria for PR: greater than or equal to (\>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to less than (\<) 200 milligrams (mg) per 24 hours. If the serum and urine M-protein were not measurable, a decrease of \>=50% in the difference between involved and uninvolved free light chain (FLC) levels was required in place of the M-protein criteria. If serum and urine M-protein were not measurable, and serum free light assay was also not measurable, \>=50% reduction in bone marrow plasma cells (PCs) was required in place of M-protein, provided baseline bone marrow PC percentage was \>=30%. In addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas was also required.
| Arm | Type | Description |
|---|---|---|
| JNJ-68284528 | EXPERIMENTAL | Single group assignment-Post lymphodepletion, JNJ-68284528 single infusion given to Part A participants: Cohort A (Progressive disease post 1-3 prior lines of therapy), Cohort B (Early relapse post front-line), Cohort C(Relapsed/refractory multiple myeloma post PI, IMiD,anti-CD38,anti-BCMA therapy), Cohort D(Less than CR post ASCT front-line therapy, some participants will receive JNJ-68284528 then lenalidomide), Cohort F(Newly diagnosed multiple myeloma \[NDMM\], standard risk \[International Staging System Stage I/II\] and post initial therapy); Cohort E(NDMM,transplant not planned, high risk disease) will first receive quadruplet induction regimen of daratumumab, bortezomib, lenalidomide and dexamethasone(D-VRd) then lymphodepletion and JNJ-68284528 then consolidation regimen of lenalidomide. Enrollment is closed for Cohorts A,B,C,D,E and F. For US sites only: Part B:Cohort G (NDMM, transplant not planned) will receive daratumumab, lenalidomide and dexamethasone followed by cilta-cel. |
| Name | Type | Description |
|---|---|---|
| JNJ-68284528 | DRUG | Participants in Cohorts A,B,C, D, E, F and Cohort G (for US sites only) will receive JNJ-68284528 intravenously. |
| Lenalidomide | DRUG | Some participants in Cohort D and all participants in Cohorts E and Cohort G (for US sites only) will also receive lenalidomide capsules orally. |
| Daratumumab | DRUG | Participants in Cohorts E and Cohort G (for US sites only) will also receive daratumumab subcutaneous (SC) injection. |
| Bortezomib | DRUG | Participants in Cohorts E will also receive bortezomib subcutaneously. |
| Dexamethasone | DRUG | Participants in Cohorts E and Cohort G (for US sites only) will also receive dexamethasone orally or intravenously. |
Inclusion Criteria: * Cohort A: Received a minimum of 1 to a maximum of 3 prior lines of therapy including a proteasome inhibitor (PI) and immunomodulatory therapy (IMiD), and lenalidomide refractory per International Myeloma Working Group (IMWG) guidelines * Cohort B: Received one line of prior th...
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JNJ-68284528 is an investigational chimeric antigen receptor T cell (CAR-T) therapy being studied for the treatment of multiple myeloma. It is directed against B-cell maturation antigen (BCMA). The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
JNJ-68284528 targets B-cell maturation antigen (BCMA), a protein expressed on the surface of multiple myeloma cells. As a CAR-T therapy, it is designed to redirect a patient's own T cells to recognize and attack BCMA-expressing tumor cells. This mechanism is being evaluated in clinical trials for relapsed or refractory multiple myeloma.
JNJ-68284528 is being developed by Johnson & Johnson, a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol JNJ. The drug is an investigational CAR-T therapy in Phase 2 clinical development for multiple myeloma.
JNJ-68284528 is in Phase 2 clinical development. It has completed a Phase 1 trial and is currently being evaluated in an active Phase 2 study. The drug is investigational and has not been approved by the FDA or other regulatory agencies.
JNJ-68284528 has been studied in two clinical trials. The first, NCT03548207, was a Phase 1 study in relapsed or refractory multiple myeloma that has been completed. The second, NCT04133636, is an active Phase 2 study in multiple myeloma that is not currently recruiting participants.
JNJ-68284528 is also known as cilta-cel, a chimeric antigen receptor T cell therapy directed against B-cell maturation antigen. It is being developed for multiple myeloma and is currently in Phase 2 clinical trials. The drug is not yet approved for commercial use.