Multiple Myeloma Clinical Trial

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

Summary

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).

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Full Description

This study will evaluate the safety and efficacy of JNJ-68284528. The study will include two phases. In Phase1b the study will enroll adults with multiple myeloma with interval assessments for potential dose escalation or de-escalation in subsequent participants. The dose selected at the completion of phase 1b will be used in Phase 2. Following consent, enrolled participants will undergo an apheresis procedure to collect cells for manufacture of investigational drug product (JNJ-68284528). Following manufacture of the drug product, participants will undergo lymphodepletion prior to infusion of JNJ-68284528. Participants will be followed for at least 2 years after study drug infusion, with long-term 15 year follow-up on a separate study. The study will evaluate safety, biomarkers, pharmacokinetic/pharmacodynamic evaluations and efficacy.

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Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

126

Study ID:

NCT03548207

Recruitment Status:

Completed

Sponsor:

Janssen Research & Development, LLC

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There are 20 Locations for this study

See Locations Near You

Mayo Clinic Cancer Center-Scottsdale
Phoenix Arizona, 85054, United States
City of Hope
Duarte California, 91010, United States
University of California, San Francisco
San Francisco California, 94143, United States
University of Chicago
Chicago Illinois, 60637, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Massachusetts General Hospital
Boston Massachusetts, 02215, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Mayo Clinic Rochester
Rochester Minnesota, 55902, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15232, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Froedtert Memorial
Milwaukee Wisconsin, 53226, United States
University Hospital Kyoto Perfectural University of Medicine
Kyoto , 602-8, Japan
Nagoya City University Hospital
Nagoya , 467-8, Japan
Hokkaido University Hospital
Sapporo-shi , 060-8, Japan
Japanese Red Cross Medical Center
Shibuya , 150-8, Japan

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

126

Study ID:

NCT03548207

Recruitment Status:

Completed

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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