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Outcomes following CD22 CAR T-cells in B-ALL: a tale of two manufacturing strategies.

Outcomes following CD22 CAR T-cells in B-ALL: a tale of two manufacturing strategies. Cytotherapy Dreyzin, A., Kramer, A. M., Yates, B., Wang, H. W., Sahaf, B., Yuan, C., Klysz, D., Tunuguntla, R., Ehlinger, Z., Reitberg, S., Adebola, S., Su, A., Ebina-Shibuya, R., Jia, D., Achar, S., Patil, S., Martin, K., Jeyakumar, N., Davis, K. L., Fry, T., Mackall, C. L., Taylor, N., Altan-Bonnet, G., Highfill, S., Feldman, S., Stroncek, D. F., Chien, C., Schultz, L. M., Frank, M. J., Muffly, L. S., Shalabi, H., Ramakrishna, S., Shah, N. N. 2025: 101990

Abstract

As use of chimeric antigen receptor (CAR) T-cells continues to grow, there is increasing interest in utilizing automated manufacturing systems as a mechanism to support decentralized manufacturing and increase access. However, most FDA approved CAR T-cell therapies are manufactured using traditional bag culture methodologies. Thus, understanding how different manufacturing platforms may impact outcomes is imperative. With parallel trials of CD22 CAR T-cells conducted in patients with B-cell acute lymphoblastic leukemia using a uniform vector but two different manufacturing strategies - either bag-culture (BC) or Prodigy - we were able to compare outcomes. Across 57 patients, 41 received BC cells and 16 received Prodigy-based cells. No significant differences in response rates or incidence of CAR-associated toxicities were observed between cohorts, although the BC cohort had slightly higher rates of severe CRS and IEC-HS. Peak ferritin and C-reactive protein levels were higher in the BC cohort. CAR T-cell expansion was similar, except for patients who had extramedullary disease with low bone marrow disease burden (n = 6 from each group), for whom BC-manufactured cells had greater expansion. In summary, while efficacy across both platforms was comparable, lower inflammatory markers in those who received Prodigy manufactured CAR T-cells suggest changes in the infusion product.

View details for DOI 10.1016/j.jcyt.2025.09.013

View details for PubMedID 41190967