资源有限环境中分散式床旁 CD19 CAR-T 细胞治疗复发大 B 细胞淋巴瘤的可行性与结局

CD19 chimeric antigen receptor (CAR) T cell therapy has transformed outcomes for patients with relapsed/refractory (R/R) large B cell lymphoma (LBCL), yet access to commercial products remains severely limited in low- and middle-income countries due to high cost, infrastructure requirements, and centralized manufacturing.

Herein, we developed and implemented a decentralized point-of-care (POC) CAR T cell platform in Thailand using an automated closed system (CliniMACS Prodigy), integrating local manufacturing with clinical delivery. Between 2020 and 2025, 12 patients with R/R LBCL (median age 45. 8 years) were treated, with a median vein-to-vein time of 12 days. Manufacturing was successful in 11 patients, while one received an out-of-specification dose.

Final products demonstrated a balanced CD4:CD8 ratio and were enriched for memory T cell subsets. Cytokine release syndrome occurred in 5 patients (grade 3 in 1), and neurotoxicity in 1 patient (grade 1). At 3 months, the overall response rate was 58. 3%, including 33. 3% complete responses. One-year event-free and overall survival were 58. 3% and 90%. The median total cost was USD 111,231.

These findings demonstrate that decentralized POC CAR T cell therapy is feasible, effective, and more affordable, supporting scalable implementation in resource-limited settings.