Outcomes of point-of-care manufactured CAR T cell therapy for B cell acute lymphoblastic leukemia and non-Hodgkin lymphoma in Vietnam.

Chimeric antigen receptor (CAR) T cell therapy has transformed the treatment of relapsed/refractory (R/R) B cell acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL), but access remains limited in resource-constrained settings. This phase I study evaluated the safety and feasibility of point-of-care (PoC) manufactured CD19-targeted CAR T cell therapy in Vietnamese patients. Between August 2023 and June 2025, 16 patients, eight with R/R ALL and eight with R/R NHL, were enrolled. All received fresh CAR T cells produced on-site using the CliniMACS Prodigy system, with a median dose of 1.9 × 106 CAR T cells/kg (range, 0.83-2.17 × 106). Cytokine release syndrome (CRS) occurred in 13 patients (12 with grade 1-2, one with grade 3), and grade 1 neurotoxicity was observed in two patients. In ALL, the complete remission (CR) rates were 100% on day 30, 75% on day 90, and 62.5% on day 180. Patients with NHL showed CR rates of 87.5% on both day 90 and day 180. The estimated 1-year progression-free survival rates were 62.5% (95% confidence interval [CI]: 36.5%-100%) for ALL and 87.5% (95% CI: 67.3%-100%) for NHL. PoC manufactured CD19 CAR T cells demonstrated manageable toxicity and encouraging early efficacy in Vietnamese patients with R/R ALL and NHL. This model offers a cost-effective strategy for delivering advanced therapy in resource-limited settings.