공시 • Jun 11
Cellectis S.A. Presents Final Phase 1 Results of Lasme-Cel and Preliminary Results on Eti-Cel At Eha 2026 Congress Cellectis S.A. presented final Phase 1 data 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), and preliminary data from the NATHALI-01 study evaluating eti-cel, a dual CD20 and CD22 directed CAR-T in relapsed/refractory B-cell non Hodgkin lymphoma (r/r B-NHL), at the European Hematology Association 2026 Annual Congress. 45 patients in third line and beyond (3L+) were treated in the BALLI-01 study. 15 patients were treated at the recommended Phase 2 dose and 7 in the target Phase 2 population. Patients were heavily pretreated with those in the target Phase 2 population receiving a median of 5 prior lines of therapy (Range 2-11). Almost all patients were previously treated with blinatumumab (82%) and were also heavily exposed to CD19 CAR-T (53%), CD22-directed antibody-drug conjugate (ADC) (56%) and many had a prior hematopoietic stem cell transplantation (HSCT) (47%). In the target Phase 2 population, an overall response rate (ORR) of 100% (7/7) was achieved with a complete remission/complete remission with incomplete count recovery (CR/CRi) rate of 57% (4/7). Of these, 75% achieved minimal residual disease negative (MRD-ve) status. All patients subsequently proceeded to HSCT. Lasme-cel demonstrated a manageable safety profile. Cytokine release syndrome (CRS) grade 3 occurred in 4% of patients. Immune effector cell-associated neurotoxicity syndrome (ICANS) grade 3 occurred in 4% of patients. Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) grade 3 occurred in 2% of patients. All CRS, ICANS, and IEC-HS resolved. The Pivotal Phase 2 BALLI-01 trial is open for recruitment. The first interim analysis is expected in Fourth Quarter 2026. Oral Presentation: Safety and efficacy of UCART22 in heavily pretreated patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia (B-ALL): results of the Phase 1 BALLI-01 trial. Date/Time: Saturday, June 13 at 5:15 - 6:30pm, local time. Session Title: Advances in the treatment of lymphoblastic leukemia. Session Room: K1. Abstract Number: 4689. Note: presentation slides will be uploaded to Cellectis' website concurrently with the live presentation. The NATHALI-01 preliminary data on the role of alemtuzumab in optimizing responses will be presented as a poster by Professor Emmanuel Bachy, M.D., Ph.D., Department of Hematology, Hospices Civils de Lyon, France. Eti-cel is a highly differentiated product being the first allogeneic dual CAR-T targeting both CD20 and CD22, for patients with r/r B-NHL. As of the February 2026 data cutoff, 14 patients with r/r B-NHL had been treated across three dose levels, in a heavily pre-treated population with a median of 3 prior lines of therapy, 93% of whom had received prior CD19-directed CAR-T therapy, and all of whom presented with stage IV disease at baseline. In the optimal dose cohort, ORR and complete response (CR) were 88% and 63%, respectively. The analysis identified a positive correlation between alemtuzumab exposure and clinical outcomes: higher alemtuzumab exposure created a favorable lower inflammatory homeostatic milieu prior to eti-cel infusion and was associated with enhanced eti-cel expansion and higher response rates. Additionally, responders maintained sustained low-level interleukin 2 (IL-2) secretion when compared to non-responders. These findings provide a scientific rationale for the implementation of a weight-based alemtuzumab dosing regimen, currently under investigation to optimize lymphodepletion. Additionally, subcutaneous low-dose IL-2 is being investigated to further enhance eti-cel expansion and treatment response. The NATHALI-01 study is open for recruitment with the full Phase 1 clinical data expected in Fourth Quarter 2026. Poster Presentation: Alemtuzumab exposure and sustained IL-2 drive UCART20x22 expansion and clinical response in adults with relapsed or refractory B-cell non-Hodgkin lymphoma: NATHALI-01 study. Date/Time: Saturday, June 13 at 6:45 - 7:45pm, local time. Session: Poster Session 2. Poster Number: 4758. Note: poster presentation will be uploaded to Cellectis' website at the opening of the poster session. 공시 • Jun 10
Cellectis S.A. Receives FDA RMAT Designation for Lasme-Cel, the First Allogeneic Car-T Therapy in A Pivotal Trial for Patients with R/R B-All Cellectis S.A. announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to lasmecabtagene timgedleucel (lasme-cel), its CD22-targeting allogeneic CAR-T cell therapy product candidate, for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). The granting of RMAT designation reflects the FDA's recognition of the potential for lasme-cel to address the unmet medical need faced by patients with r/r B-ALL. The RMAT designation is supported by Phase 1 BALLI-01 data demonstrating promising efficacy and a manageable safety profile. Final Phase 1 data from the BALLI-01 trial of lasme-cel will be presented in an oral session at the 2026 Congress of the European Hematology Association (EHA) this Saturday, June 13 at 5:15 – 6:30pm CET by Nitin Jain, M.D., Professor of Medicine, Department of Leukemia at MD Anderson Cancer Center in Houston. The BALLI-01 trial Pivotal Phase 2 is open for enrollment. Information on participant eligibility and participating clinical centers can be found on clinicaltrials: BALLI-01 (NCT04150497). 공시 • May 22
Cellectis S.A., Annual General Meeting, Jun 25, 2026 Cellectis S.A., Annual General Meeting, Jun 25, 2026. Location: at the biopark auditorium, 11 rue watt, 4th floor, 75013., paris France 공시 • May 05
Cellectis S.A. to Report Q1, 2026 Results on May 11, 2026 Cellectis S.A. announced that they will report Q1, 2026 results After-Market on May 11, 2026 공시 • Apr 29
Cellectis Presents Epigenetic Editing Platform To Turn Genes Off Without Altering DNA Cellectis presented new research on a TALE-based epigenetic editing approach, that does not cut or permanently modify the DNA sequence, making it a potentially safer alternative for genome editing, at the American Society of Gene and Cell Therapy annual meeting, that will be held on May 11-15, in Boston (MA). The data will be presented in a poster: Title: TALE-based epigenetic modulators show sustained knock-down of target genes in T-cells and HEPG2 via a high-throughput multiplex screening platform. Transcription activator-like effector-based epigenetic modulators (TALEM) are engineered fusion proteins consisting of a TALE DNA-binding domain with functional domains that mediate epigenetic modifications. These proteins can be precisely guided to a target location in the genome to switch genes on or off through a process known as epigenetic editing. Unlike traditional gene editing tools, this approach does not induce DNA breaks and DNA sequence modifications, making it a potentially safer alternative for genome editing. In this work, Cellectis developed a high-throughput screening system capable of rapidly assembling and testing hundreds of these TALEM, identifying which combinations are most effective at regulating a given gene. This strategy was used for two distinct genes: one highly expressed in hepatocytes (active in liver cells) and another implicated in T-cell dysfunction and exhaustion, a key challenge in cancer immunotherapy. In both cases, the approach achieved >90% reduction in gene activity, which remained stable throughout the study. 공시 • Mar 13
Cellectis S.A. to Report Q4, 2025 Results on Mar 19, 2026 Cellectis S.A. announced that they will report Q4, 2025 results at 5:40 PM, Central European Standard Time on Mar 19, 2026 
