Carbone Cancer Center Clinical Trials

Protocol No.	UW23059 BB2121-EAP-001
Principal Investigator	Callander, Natalie
Phase	N/A
Age Group	Adult
ClinicalTrials.Gov	NCT04771078 (Click to jump to clinicaltrials.gov)
Management Group(s)	Myeloma
Management Group(s)	Myeloma
Title Expanded Access Protocol (EAP) for Subjects Receiving Idecabtagene Vicleucel that is Nonconforming for Commercial Release Description This study is designed to evaluate the safety and efficacy of nonconforming idecabtagene vicleucel (ide-cel) in participants with multiple myeloma per the approved prescribing information. This is an expanded access protocol (EAP) to be conducted at Risk Evaluation and Mitigation Strategies (REMS) qualified sites approved for commercial administration of idecabtagene vicleucel and where the EAP is authorized to be conducted for use of nonconforming idecabtagene vicleucel. Non-conforming idecabtagene vicluecel is idecabtagene vicleucel that does not meet commercial release specifications but may be acceptable for use as an investigational product in the Expanded Access Protocol setting. Objective The primary objective is to assess the safety of nonconforming ide-cel. The secondary objective is to assess efficacy of nonconforming ide-cel. The exploratory objectives are to assess duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Treatment Biological: Nonconforming idecabtagene vicleucel Nonconforming idecabtagene vicleucel is to be administered to participants after lymphodepleting chemotherapy Other Name: BB2121 Key Eligibility Inclusion Criteria: Had a participant-specific batch of Idecabtagene vicleucel (ide-cel) manufactured intended for commercial treatment; however, the final manufactured product was nonconforming and did not meet commercial release criteria Remanufacturing is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the participant Clinically stable Exclusion Criteria: Has a hypersensitivity to the active substance or to any of the excipients No experience of a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of Adverse Events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming Idecabtagene vicleucel (ide-cel) Has any condition and/or laboratory abnormality that places the participant at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement Other protocol-defined inclusion/exclusion criteria apply Applicable Disease Sites Multiple Myeloma Participating Institutions UW Health University Hospital