Single-center phase 1 trial of IL-10-expressing, anti-CD19 CAR T cells for relapsed or refractory B-cell acute lymphoblastic leukemia
A phase 1 trial at the University of Science and Technology of China (Hefei) evaluated IL-10-expressing, anti-CD19 CAR T cells (‘META 10-19’) for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). META 10-19 was given in low doses (0.1 to 0.2 x 106 cells per kg). Grade 3 or 4 adverse events were seen in all patients; there were no grade 5 AEs. Grade 1 or 2 CRS was seen in 92%; no patient had ICANS. Overall response at 1 month was observed in 100% of patients, with complete response in 33%, complete response with incomplete hematological recovery in 42%, and morphological leukemia-free state in 25%. The authors conclude that META 10-19 at low doses showed a manageable safety profile and promising activity in patients with R/R B-ALL.