Clinical TrialJun 11, 2026, 07:01 AM
Cellectis Presents Positive Phase 1 Data for Lasme-cel & Eti-cel CAR-T
AI Summary
Cellectis presented positive final Phase 1 results for lasme-cel in relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) and preliminary data for eti-cel in r/r B-cell non-Hodgkin lymphoma (r/r B-NHL) at the EHA 2026 Congress. Lasme-cel achieved a 100% overall response rate in the target Phase 2 population, with a manageable safety profile, and its pivotal Phase 2 trial is now recruiting. Eti-cel demonstrated an 88% ORR in its optimal dose cohort, with findings suggesting alemtuzumab optimization can enhance CAR-T expansion and response.
Key Highlights
- Lasme-cel (BALLI-01) achieved 100% overall response rate (ORR) in 7 r/r B-ALL patients in target Phase 2 population.
- Lasme-cel showed 57% complete remission/CRi and 75% minimal residual disease negative status in target Phase 2 population.
- Lasme-cel demonstrated manageable safety with 4% grade 3+ CRS, 4% grade 3+ ICANS, and 2% grade 3+ IEC-HS.
- Eti-cel (NATHALI-01) achieved 88% ORR and 63% complete response in optimal dose cohort for r/r B-NHL patients.
- Eti-cel data showed a positive correlation between alemtuzumab exposure and enhanced CAR-T expansion and response rates.
- The pivotal Phase 2 BALLI-01 trial for lasme-cel is open for recruitment, with first interim analysis expected Q4 2026.
- The NATHALI-01 study for eti-cel is open for recruitment, with full Phase 1 data expected in Q4 2026.
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