NCT04133636

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

A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Multiple Myeloma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	JNJ-68284528	Participants in Cohorts A,B,C, D, E, F, G, and H will receive JNJ-68284528 intravenously.
DRUG	Lenalidomide	Some participants in Cohort D and all participants in Cohorts E, G, and H will also receive lenalidomide capsules orally.
DRUG	Daratumumab	Participants in Cohorts E, G, and H will also receive daratumumab subcutaneous (SC) injection.
DRUG	Bortezomib	Participants in Cohorts E and H will also receive bortezomib subcutaneously.
DRUG	Dexamethasone	Participants in Cohorts E, G, and H will also receive dexamethasone orally or intravenously.

Timeline

• Start date: 2019-11-07
• Primary completion: 2026-08-04
• Completion: 2029-09-03
• First posted: 2019-10-21
• Last updated: 2026-04-13

Locations

47 sites across 8 countries: United States, Belgium, France, Germany, Israel, Netherlands, Saudi Arabia, Spain

Regulatory

• FDA-regulated drug study