The following is a summary of “Treatment of adult ALL patients with third-generation CD19-directed CAR T cells: results of a pivotal trial,” published in the July 2023 issue of Hematology by Schubert et al.
Chimeric antigen receptor (CAR)–engineered T cells (CARTs) may improve clinical outcomes for patients with B cell malignancies. Researchers started a retrospective study to assess the safety and efficacy of third-generation CARTs in adult patients with refractory and/or relapsed (r/r) acute lymphoblastic leukemia (ALL).
They treated13 patients with CD19-directed CARTs, with doses ranging from 1 × 106 to 50 × 106 CARTs/m2. The leukapheresis, manufacturing, and CARTs administration processes were carried out in-house.
The results showed CART manufacturing was feasible for all patients. No patients developed Immune effector cell-associated neurotoxicity syndrome (ICANS) or higher-grade (≥ grade III) cytokine release syndrome (CRS). CART expansion and long-term persistence were observed in evaluable patients’ peripheral blood (PB). After 90 days of CART administration, ten patients were evaluated for response, with eight patients (80%) achieving complete remission (CR), including 5 patients (50%) with minimal residual disease (MRD)-negative CR. Response and outcomes correlated with the CART dosage. At the 1-year follow-up, median overall survival was not reached, while progression-free survival (PFS) was 38%, with a median PFS run by day 120. Responder CART products more frequently lacked CD39 expression on memory-like T cells than non-responders. High CD8+ and γδ-T cells and low monocytes in the blood after CART administration were linked to a positive response.
They concluded that third-generation CARTs show promising efficacy and low toxicity for adults with r/r ALL.
Source: jhoonline.biomedcentral.com/articles/10.1186/s13045-023-01470-0