Journal article
Preleukapheresis Risk Factors for BCMA CAR-T cell Product Manufacturing Failure
Blood immunology & cellular therapy, Vol.2(3), 100068
09/2026
DOI: 10.1016/j.bict.2026.100068
Abstract
B-cell maturation antigen–directed chimeric antigen receptor T-cell therapies have transformed the treatment of relapsed/refractory multiple myeloma (MM). Manufacturing failures are a barrier to therapy delivery. Understanding modifiable risk factors of manufacturing failures could improve patient selection and leukapheresis timing. We conducted a multicenter retrospective case-control study of patients with MM who underwent leukapheresis for idecabtagene vicleucel (ide-cel) or ciltacabtagene autoleucel (cilta-cel) manufacturing between 2021 and 2024. We analyzed the relationship between prior therapy exposure and manufacturing outcomes, with a focus on the length of time since last exposure by drug class. Among the 43 patients (30 ide-cel and 13 cilta-cel), 8 (18.6%) experienced manufacturing failures. Exposure to alkylating agents was associated with lower odds of manufacturing success. Every additional month from last exposure to alkylating agents resulted in a 7% reduction in odds of manufacturing failure (odds ratio, 0.93; 95% confidence interval, 0.87-0.98; P < .01). No significant associations were identified between manufacturing failure and time since exposure to proteasome inhibitors, immunomodulatory drugs, anti-CD38 antibodies, or selinexor. Differences in patient/disease characteristics were not associated with manufacturing failure. Optimizing the timing of leukapheresis relative to alkylating agent exposure may reduce manufacturing failure rates. Larger multicenter studies are needed to validate these findings and assess the impact of new agents.
Details
- Title: Subtitle
- Preleukapheresis Risk Factors for BCMA CAR-T cell Product Manufacturing Failure
- Creators
- Samantha Sparrow - University of IowaAllyson Wolcott - University of IowaSarah Mott - University of IowaJames Davis - Medical University of South CarolinaJames McCollough - University of IowaHira Shaikh - University of IowaChristopher Strouse - University of Iowa
- Resource Type
- Journal article
- Publication Details
- Blood immunology & cellular therapy, Vol.2(3), 100068
- DOI
- 10.1016/j.bict.2026.100068
- ISSN
- 3050-5976
- eISSN
- 3050-5976
- Publisher
- Elsevier
- Language
- English
- Electronic publication date
- 06/2026
- Date published
- 09/2026
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9985217067202771
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