A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma
Trial ID or NCT#
NCT05347485
Status
RECRUITING
Purpose
The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS).
Official Title
A Safety and Efficacy Study of JNJ-68284528 (Ciltacabtagene Autoleucel) Out-of-Specification (OOS) for Commercial Release in Patients With Multiple Myeloma
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Surbhi Sidana, MD
Blood and marrow transplant specialist,
Hematologist-Oncologist
Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Contact us to find out if this trial is right for you.
Contact
Kristin Ana-Marie Muller
+1 650-725-1647
View on ClinicalTrials.gov
