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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


Active: Yes
Cancer Type: Multiple Myeloma
Plasma cell neoplasm
NCT ID: NCT04133636
Trial Phases: Phase II Protocol IDs: CR108581 (primary)
2018-004124-10
68284528MMY2003
NCI-2019-07363
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Janssen Research & Development, LLC
NCI Full Details: http://clinicaltrials.gov/show/NCT04133636

Summary

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

Objectives

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, handwriting assessment, 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. For
certain participants (those without measurable disease in serum or urine) efficacy will be
assessed via imaging: positron emission tomography/ computed tomography (PET/CT) or whole
body magnetic resonance imaging (MRI). The overall duration of the study is up to 2.5 years.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.