• 84% ORR (32 of 38 patients) and 71% CR (27 of 38 patients) documented after 2 million cells/kg dose anbal-cel treatment to patients in relapsed/refractory large B-cell lymphoma
• Durable complete response was measured-68% at 1 month, 61% at 3 months, and 60% at 6 months respectively.

The anbal-cel is the next-generation OVIS^TM technology applied to anti-CD19 CAR-T using the 4-1BB domain as a co-stimulation domain as and also it consists of a dual knockdown system for two immune checkpoint receptors, PD-1 and TIGIT, in CAR-T cells. 

The Phase 2 study of anbal-cel was conducted to evaluate the efficacy and safety in patients with r/r LBCL. Patients with relapsed or refractory LBCL were enrolled in six Korean investigator sites to receive anbal-cel at a dose of 2x10⁶ CAR-T cells/kg.

41 patients with r/r LBCL were infused with anbal-cel. All patients received two or more prior lines of therapy and 10% (4 of 41) received ≥4 prior lines of treatment before the study.

84% ORR (32/38), 71% CR (27/38) were reached, and durable complete response was monitored as CR at 1 month was 68% (26/38), CR at 3 months was 61% (19/31) and CR at 6 months was 60% (12/20) where median follow-up as 6.3 months.

Grade 3 CRS and ICANS were reported from 14.6% (6/41), and 7.3% (3/41) respectively. No grade 4 CRS and ICANS were observed. Prolonged neutropenia, cytopenia, and serious infection were observed in 31.7% of patients (13/41), 49% of patients (20/41), and 10% of patients (4/41) respectively.

Curocell is planning on submitting an NDA to MFDS in mid-2024 and recently completed the construction of the largest commercial GMP facility for CAR-T production in Daejeon, Korea.