251 Product characterization of a clinical-grade BCMA CAR-MIL therapy supports IND-enabling development for multiple myeloma
Year: 2026
Type: conference-abstract
Abstract: Background Marrow-infiltrating lymphocytes (MILs) are a promising cellular platform for multiple myeloma because they are enriched for tumor-reactive T cells while providing a suitable substrate for chimeric antigen receptor (CAR) engineering. As BCMA CAR-MIL therapy advances toward clinical evaluation, comprehensive characterization of the final cell product is essential to establish manufacturing consistency, product quality, and translational readiness.Methods BCMA CAR-MILs were generated from bone marrow-derived MILs using a GMP-manufactured BCMA lentiviral vector and an optimized GMP-compatible 10-day manufacturing process. The final cell product was evaluated for manufacturing consistency, viability, CAR expression, expansion, T-cell differentiation, activation status, exhaustion profile, functional potency, and product stability. Product characterization was performed to support IND-enabling development. GLP studies evaluating safety, biodistribution, and antitumor activity are currently underway.Results The optimized manufacturing process consistently generated clinical-scale BCMA CAR-MIL products within 10 days while maintaining high viability and reproducible CAR expression. The final products demonstrated a central memory-enriched phenotype with limited expression of exhaustion-associated markers and preserved functional activity against BCMA-positive myeloma cells. Product characterization demonstrated attributes supporting product identity, viability, potency, and quality suitable for IND-enabling development. These findings established a reproducible manufacturing process and a well-characterized clinical-grade cell product suitable for IND-enabling development.Conclusions Comprehensive characterization of GMP-manufactured BCMA CAR-MIL products demonstrated reproducible manufacturing, favorable cellular attributes, and preserved functional activity. These findings support ongoing IND-enabling studies and advancement toward first-in-human clinical evaluation in patients with multiple myeloma.
Institution: Chonnam National University Hwasun Hospital
Language: English
Topic: CAR-T cell therapy research
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,490
OpenAlex ID: W7225187738