Prulacabtagene leucel (prula-cel, formerly ADI-001)

June 30, 2026: Adicet Bio (NASDAQ: ACET) said its Phase 1 update for prulacabtagene leucel (prula-cel, formerly ADI-001) in lupus nephritis (LN) and systemic lupus erythematosus (SLE) is now expected in 3Q/2026, with data from 22 patients (16 LN, 6 SLE) with at least 6 months’ follow-up, including 13 with at least 12 months. The company said FDA interactions are informing a potential pivotal LN trial design, with startup activities planned for 2H/2026 pending regulatory clearance; more details are expected with the 3Q/2026 update. Adicet also said LN and SLE patients in current and future studies may be dosed in an outpatient setting following FDA alignment in November 2025. Additional prula-cel clinical updates in systemic sclerosis are expected in 2H/2026.

For ADI-212, a PSMA-targeted cell therapy for metastatic castration-resistant prostate cancer (mCRPC), Adicet expects a regulatory filing in 3Q/2026 and Phase 1 enrollment initiation in 4Q/2026, pending clearance.

The company also plans a comprehensive update on its in vivo CAR-T platform and pipeline in 2H/2026. Cash, cash equivalents, and short-term investments were $118.2 million as of June 30, 2026, with runway projected into 2H/2027.