A Safety and Efficacy Study of JNJ-68284528 (Ciltacabtagene Autoleucel) Out - of - Specification (OOS) for Commercial Release in Patients with Multiple Myeloma

Fujikawa Ei0 个研究点目标入组 330 人开始时间: 2023年1月30日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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

•- 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

发起方

Fujikawa Ei