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

Completed · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

The purpose of the study is to characterize safety of JNJ-68284528 and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the efficacy of JNJ-68284528 (Phase 2).

Key facts

Study ID: NCT03548207
Run by: Janssen Research & Development, LLC
People needed: 126
Starts: 2018-06-29
Expected to finish: 2022-08-23
Last updated by the study team: 2025-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Have documented diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
Have measurable disease at Screening as defined by any of the following a) Serum monoclonal paraprotein (M-protein) level more than or equal to (>=) 1.0 gram per deciliter(g/dL) or urine M-protein level >=200 milligram per 24 hours (mg/24hr); or b) Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
Have received at least 3 prior multiple myeloma treatment lines of therapy or are double refractory to an immunomodulatory drug (IMiD) and proteasome inhibitor (PI) (refractory multiple myeloma as defined by IMWG consensus criteria). Note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single lines of therapy a) Undergone at least 1 complete cycle of treatment for each line of therapy, unless progressive disease (PD) was the best response to the regimen
Have received as part of previous therapy a PI, an IMiD, and an anti-CD38 antibody
Participant must have documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria on or within 12 months of their last line of therapy. Confirmation may be from either central or local testing. Also, participants with documented evidence of progressive disease (as above) within the previous 6 months and who are refractory or non-responsive to their most recent line of therapy afterwards are eligible
Have Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1

You may not qualify if…

Have received prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target
Have received any therapy that is targeted to B-cell maturation antigen (BCMA)
Have following cardiac conditions: a) New York Heart Association (NYHA) stage III or IV congestive heart failure b) Myocardial infarction or coronary artery bypass graft (CABG) less than or equal to (<=) 6 months prior to enrollment c) History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration d) History of severe non-ischemic cardiomyopathy e) Impaired cardiac function (left ventricular ejection fraction [LVEF] less than [<]45%) as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan (performed less than or equal to (<=) 8 weeks of apheresis)
Received a cumulative dose of corticosteroids equivalent to >= 70 mg of prednisone within the 7 days prior to apheresis
Have received either of the following: a) An allogenic stem cell transplant within 6 months before apheresis. Participants who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease (GVHD) b) An autologous stem cell transplant less than or equal to (<=) 12 weeks before apheresis
Have known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma

Where it is running

Mayo Clinic Cancer Center-Scottsdale — Phoenix, Arizona, United States
City of Hope — Duarte, California, United States
University of California San Francisco — San Francisco, California, United States
University of Chicago — Chicago, Illinois, United States
Dana Farber Cancer Institute — Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
Mayo Clinic Rochester — Rochester, Minnesota, United States
University of Nebraska Medical Center — Omaha, Nebraska, United States
Mount Sinai Medical Center — New York, New York, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Levine Cancer Institute — Charlotte, North Carolina, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute — Nashville, Tennessee, United States
Froedtert Memorial — Milwaukee, Wisconsin, United States
University Hospital Kyoto Prefectural University of Medicine — Kyoto, Japan
Nagoya City University Hospital — Nagoya, Japan
Hokkaido University Hospital — Sapporo, Japan
Japanese Red Cross Medical Center — Shibuya City, Japan

Full record on ClinicalTrials.gov

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