A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma

• Status: Recruiting
• Trial end date: 2026-05-08
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Scientific Affairs, LLC
• Treatments: Cyclophosphamide; Fludarabine

Criteria

Inclusion Criteria:

• Eligible for treatment with cilta-cel per United States prescribing information (USPI) or locally approved label

• Participant is suffering from serious or life threatening multiple myeloma per USPI (or locally approved label, respectively), and re-apheresis, re-manufacturing, or other anti-myeloma directed therapies is not considered feasible or adequate per investigator

• Has adequate general health status and organ function per investigator assessment and meets the criteria to receive cilta-cel out-of-specifications (OOS)

• Meets the criteria to receive lymphodepleting chemotherapy

• A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at consenting and prior to the first dose of cyclophosphamide and fludarabine

Exclusion Criteria:

• History of active uncontrolled infection or condition where an administration of cilta-cel OOS constitutes serious health risk to the participant

• Known allergies, hypersensitivity, or intolerance to the excipients of cilta-cel OOS including dimethyl sulfoxide (DMSO), dextran 40, or residual kanamycin per USPI

• Hepatitis B infection

• Hepatitis C infection defined as (anti hepatitis C virus [HCV] antibody positive or detectable HCV ribonucleic acid [RNA]) or known to have a history of hepatitis C

• Seropositive for human immunodeficiency virus (HIV)

• Uncontrolled autoimmune disease