Expanded Access Protocol (EAP) for Participants Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release

Summary

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.

Timeline

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Completion

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Publications

• Sidana S, Lin Y, Cowan AJ, Rodriguez-Otero P, Scheid C, Mueller PJ, Broussard C, Krengel P, Li Y, Piault R, Corrao A, Ho C, Patel K. Idecabtagene vicleucel manufacturing and clinical value of out-of-specification products in relapsed and refractory MM. Blood Adv. 2026 Jun 9;10(11):3769-3776. doi: 10.1182/bloodadvances.2025017186.

Drugs

Indications