NEW YORK, NY, June 11, 2026
Cellectis announced final Phase 1 results from the BALLI-01 clinical trial evaluating lasme-cel, a CD22-directed allogeneic CAR-T therapy, in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), alongside preliminary findings from the NATHALI-01 study evaluating eti-cel, a dual CD20/CD22 allogeneic CAR-T therapy, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL). The data were presented at the European Hematology Association (EHA) 2026 Congress, highlighting promising efficacy and manageable safety profiles in heavily pretreated patient populations with limited treatment options.
Lasme-cel Demonstrates Strong Responses in Advanced B-ALL
The final Phase 1 results from the BALLI-01 study demonstrated encouraging clinical activity in patients who had received multiple prior treatments, including blinatumomab, CD19 CAR-T therapies, CD22-directed antibody-drug conjugates, and hematopoietic stem cell transplantation (HSCT). Among patients in the target Phase 2 population, lasme-cel achieved a 100% overall response rate (ORR), with 57% achieving complete remission or complete remission with incomplete count recovery (CR/CRi). Additionally, 75% of responding patients achieved minimal residual disease-negative (MRD-negative) status, indicating deep and meaningful responses. All responding patients subsequently proceeded to HSCT, supporting lasme-cel’s potential role as a bridge-to-transplant therapy.
Manageable Safety Profile Supports Continued Development
Lasme-cel demonstrated a manageable safety profile, with low rates of severe treatment-related adverse events. Grade 3 or higher cytokine release syndrome (CRS) occurred in only 4% of patients, while severe immune effector cell-associated neurotoxicity syndrome (ICANS) was reported in 4%, and severe immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) occurred in 2% of patients. Importantly, all reported CRS, ICANS, and IEC-HS events resolved successfully. Based on these results, the pivotal Phase 2 BALLI-01 trial remains actively recruiting patients, with the first interim analysis expected in Q4 2026.
Advertisement
Eti-cel Shows Encouraging Activity in Relapsed/Refractory B-NHL
Preliminary findings from the NATHALI-01 study highlighted the potential of eti-cel, the first allogeneic dual-targeting CD20/CD22 CAR-T therapy, in patients with advanced B-cell non-Hodgkin lymphoma. Among patients treated in the optimal dose cohort, eti-cel achieved an 88% overall response rate and a 63% complete response rate, despite the majority of participants having previously received CD19-directed CAR-T therapies and presenting with advanced Stage IV disease. Researchers identified a positive relationship between alemtuzumab exposure and treatment outcomes, with higher exposure associated with improved CAR-T expansion and enhanced response rates. Sustained low-level interleukin-2 (IL-2) secretion was also observed among responders, providing further insights into factors that may improve treatment durability.
Advancing Next-Generation Allogeneic CAR-T Therapies
The latest EHA data reinforce Cellectis’ leadership in gene-edited allogeneic CAR-T therapies, showcasing the potential of both lasme-cel and eti-cel to address significant unmet needs in hematologic cancers. Ongoing studies are evaluating optimized lymphodepletion strategies and supportive approaches to further enhance CAR-T expansion and persistence. Full Phase 1 data from the NATHALI-01 study are expected in Q4 2026, while continued enrollment in the BALLI-01 pivotal trial aims to support future regulatory advancement.
Source: Cellectis, press release
