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February 1, 2026Transplantation and Cellular Therapy

Ciltacabtagene Autoleucel out-of-Specification Manufacturing Outcomes Improve with Earlier Lines of Therapy

Robert Bowden Gourav Choudhary Lisa R. Kallenbach Victoria R. Alegria Octavio Costa Filho Matthew Perciavalle James Salmon Jay Kang Michael Mondon Jill Vanak Daniel Ciccone Peter G. Millili Monica Onorata Hannelore Van Eeckhoutte Vicki Plaks Maximilian Merz

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Key Points

Improved manufacturing outcomes are associated with earlier lines of therapy for ciltacabtagene autoleucel.
Key metrics demonstrate a significant reduction in out-of-specification rates when earlier therapies are administered.
Analysis of manufacturing processes indicates that adjustments can lead to better performance metrics across therapy lines.
May enable more effective use of ciltacabtagene autoleucel in treatment regimens, potentially enhancing patient outcomes.

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Implication

Observational analysis shows improved manufacturing outcomes with earlier lines of therapy, suggesting enhanced efficiency.

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Cite This Study

Bowden et al. (2026) studied this question.

synapsesocial.com/papers/69a760b6c6e9836116a2db4e https://doi.org/10.1016/j.jtct.2025.12.233

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