Relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)
CLLSCellectisCatalyst overview
Research summary
This catalyst tracks a Phase 2 data readout for UCART22 in Relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) . The expected timing is based on the latest available company guidance and may change.
BALLI-01 trial. Currently enrolling patients. Presented poster at ASH '23. 11/06/23 - Trial ongoing. 10/16/25- Presented Ph1 dataset at R&D day. Pivotal Ph2 trial initiated. 11/07/25:- ASH 2025 poster on Dec 8, 2025; Ph2 BALLI-01 first interim analysis expected in Q4 2026. 05/12/26:- BALLI-01 Ph1 full dataset at EHA Jun 13, 2026. Pivotal Ph2 interim data Q4 2026. 05/11/26:- BALLI-01 pivotal Ph2 first interim analysis Q4 2026; BLA submission anticipated 2028; Ph1 full dataset EHA Jun 13, 2026. 06/09/26:- FDA granted RMAT to lasme-cel for r/r B-ALL; final Ph1 BALLI-01 data at EHA Jun 13, 2026. 06/11/26:- Final Ph1 BALLI-01 data presented Jun 13, 2026; Ph2 first interim analysis expected Q4 2026. 08/06/26:- BALLI-01 gained RMAT; full Ph1 data presented; Ph2 interim Q4 2026; BLA 2028.
Verification
Confirm timing and program details against the company announcement or filing.