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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Cilta-cel; Drug: Lymphodepleting Therapy (Cyclophosphamide and Fludarabine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05347485

CR109014

68284528MMY2005 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 during screening 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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86 participants in 1 patient group

Ciltacabtagene Autoleucel (Cilta-cel)

Experimental group

Description:

Eligible participants will receive bridging therapy (that is, anti-plasma cell directed treatment) based on participant's clinical status and timing of availability of cilta-cel (JNJ-68284528) along with lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] and fludarabine 30 mg/m\^2 IV daily, for 3 days). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants will receive a single IV infusion of cilta-cel (JNJ-68284528) at a total targeted dose of 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (cells/kg).

Treatment:

Drug: Lymphodepleting Therapy (Cyclophosphamide and Fludarabine)

Drug: Cilta-cel