Cellectis presented final Phase 1 data from the BALLI-01 clinical trial evaluating lasme-cel in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), and preliminary data from the NATHALI-01 study evaluating eti-cel in relapsed or refractory B-cell non-Hodgkin lymphoma (r/r B-NHL), at the European Hematology Association (EHA) 2026 Annual Congress. The data for lasme-cel, a CD22-directed allogeneic CAR-T therapy, demonstrated an overall response rate (ORR) of 100% in the target Phase 2 population, highlighting its potential to address unmet medical needs for heavily pretreated patients.

In the target Phase 2 population of the BALLI-01 study, 7 patients achieved an ORR of 100% (7/7) with a complete remission/complete remission with incomplete count recovery (CR/CRi) rate of 57% (4/7). Of these patients, 75% achieved minimal residual disease negative (MRD-ve) status, and all subsequently proceeded to hematopoietic stem cell transplantation (HSCT). The therapy demonstrated a manageable safety profile, with cytokine release syndrome (CRS) ≥ grade 3 occurring in 4% of patients, immune effector cell-associated neurotoxicity syndrome (ICANS) ≥ grade 3 in 4%, and immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) ≥ grade 3 in 2%. All cases of CRS, ICANS, and IEC-HS resolved.

The NATHALI-01 study evaluated eti-cel, the first allogeneic dual CAR-T targeting both CD20 and CD22, in 14 patients with r/r B-NHL. As of the February 2026 data cutoff, patients were heavily pretreated with a median of 3 prior lines of therapy, and 93% had received prior CD19-directed CAR-T therapy. In the optimal dose cohort, the ORR was 88% and the complete response (CR) rate was 63%. The analysis identified a positive correlation between alemtuzumab exposure and clinical outcomes, where higher exposure created a favorable lower inflammatory homeostatic milieu prior to infusion and was associated with enhanced eti-cel expansion.

Key Clinical Data Summary

Clinical Trial Status

The Pivotal Phase 2 BALLI-01 trial is open for recruitment, with the first interim analysis expected in Q4 2026. The NATHALI-01 study is also open for recruitment, with full Phase 1 clinical data expected in Q4 2026. "These final Phase 1 results are particularly meaningful for a patient population that has very limited treatment options," said Nitin Jain, M.D., Professor of Medicine at the University of Texas MD Anderson Cancer Center.