Last updated on June 2020

A Study of JNJ-68284528 a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma


Brief description of study

The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.

Detailed Study Description

Multiple myeloma is characterized by the production of monoclonal immunoglobulin (Ig) proteins or protein fragments (M proteins) that have lost their function. The main aim of the study is to determine the safety and efficacy of JNJ-68284528 in various clinical settings. JNJ-68284528 is an autologous chimeric antigen receptor T-cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA). The study comprises of a Screening Phase (less than or equal to [<=] 28 days prior to apheresis) followed by Apheresis (will occur upon enrollment); a Treatment Phase including a conditioning regimen followed by infusion of JNJ-68284528 and post-infusion assessments from Day 1 to Day 100 (participants who receive an infusion of JNJ-68284528 should continue all subsequent assessments); and a Post-treatment Phase (Day 101 and up to the end of each study cohort). Safety evaluations will include a review of adverse events, laboratory test results, vital sign measurements, physical examination findings (including neurologic examination), assessment of cardiac function, immune effector cell-associated encephalopathy (ICE) score, and assessment of Eastern Cooperative Oncology Group (ECOG) performance status grade. Efficacy evaluations will include measurements of tumor burden/residual disease, myeloma proteins, bone marrow examinations, skeletal surveys, extramedullary plasmacytomas, and serum calcium corrected for albumin. The overall duration of the study is up to 2.5 years.

Clinical Study Identifier: NCT04133636

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Emory University

Atlanta, GA United States
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Northwestern University

Chicago, IL United States
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University of Chicago

Chicago, IL United States
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Indiana University

Indianapolis, IN United States
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Johns Hopkins

Baltimore, MD United States
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Mount Sinai Medical Center

New York, NY United States
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University of Pennsylvania

Philadelphia, PA United States
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University of Pittsburgh

Pittsburgh, PA United States
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UZ Gent

Gent, Belgium
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UZ Leuven

Leuven, Belgium
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VU Medisch Centrum

Amsterdam, Netherlands
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Recruitment Status: Open


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