Idecabtagene vicleucel manufacturing and clinical value of out of specification products in relapsed and refractory MM - PubMed
6 hours ago
- #CAR T-cell therapy
- #manufacturing quality
- #multiple myeloma
- Idecabtagene vicleucel (ide-cel) is an approved CAR T-cell therapy for relapsed or refractory multiple myeloma.
- Out-of-specification (OOS) products, which do not meet commercial release criteria, are investigational but can be administered under an expanded access protocol.
- Manufacturing success rates improved from 95.3% in 2021 to 96.8% in 2024, with reduced turnaround time (from 31 days to 24 days).
- In the BB2121-EAP-001 study, OOS ide-cel showed an overall response rate of 75.4% and a complete response rate of 35.4%.
- Safety data reported cytokine release syndrome in 72.3% of patients (mostly mild to moderate) and neurological toxicities in 16.0%.
- The findings support that OOS ide-cel maintains clinical efficacy and safety, with reliable manufacturing performance.