NS7CAR-T in T-ALL/T-LBL: Long-term outcomes from a phase I trial

Results from a phase I clinical trial (NCT04572308) evaluating NS7CAR-T, a naturally selected (NS) CD7-specific chimeric antigen receptor (CAR) T-cell therapy, in 171 patients with relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (T-LBL) were presented by Xian Zhang at the European Hematology Association (EHA) 2026 Congress, June 11–14, 2026, Stockholm, SE. Endpoints included overall survival (OS) and progression-free survival (PFS).

Key data: At 30 days post-infusion, 90.6% of patients achieved a bone marrow (BM) complete response (CR) / CR with incomplete hematologic recovery (CRi), with 88.8% being measurable residual disease (MRD)-negative. At a median follow-up of 814 days, the 2-year OS and PFS rates were 75.1% and 69.8%, respectively. Among patients with a CR, 88.4% proceeded to bridging allogeneic hematopoietic stem cell transplantation (allo-HSCT). The 2-year OS and PFS rates were significantly higher in patients with vs without bridging allo-HSCT (both p < 0.001) and patients with STIL::TAL1− vs STIL::TAL1+ disease (OS: p = 0.042 and PFS: p = 0.027), while only OS was significantly higher in patients undergoing first vs second allo-HSCT (p = 0.008). Grade ≥3 cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 7.0% and 2.3% of patients, respectively.

Key learning: NS7CAR-T achieved high rates of CR/CRi in patients with R/R T-ALL or LBL, though durable disease control relies on consolidative allo-HSCT, particularly in patients with genetic risk factors.