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

December 31, 2025: Adicet Bio, Inc. (NASDAQ: ACET) reported Q4/full-year 2025 results and outlined upcoming catalysts for its allogeneic gamma delta T-cell programs.

Prulacabtagene leucel (prula-cel; formerly ADI-001) – autoimmune (Phase 1): The ongoing Phase 1 study across multiple autoimmune indications (including lupus nephritis [LN], systemic lupus erythematosus [SLE], and systemic sclerosis [SSc]) is enrolling ahead of expectations; prula-cel has FDA Fast Track for relapsed/refractory Class III/IV LN, refractory SLE with extrarenal involvement, and SSc. The company expects a clinical update in 1H/2026 and an additional update in 2H/2026. Adicet plans to meet with FDA in 2Q/2026 to inform potential pivotal trial design and, subject to regulatory clearance, expects to initiate a pivotal study in LN (or LN and SLE) in 2H/2026. In November 2025, FDA alignment enabled outpatient dosing for LN and SLE patients in ongoing/future trials. A Phase 1 RA study dosed its first patient in October 2025; next update expected 2H/2026.

ADI-212 – mCRPC (preclinical/IND-enabling): Regulatory filing planned for 3Q/2026; Phase 1 enrollment expected to begin in 4Q/2026 pending clearance. Preclinical data were presented in October 2025 at the Prostate Cancer Foundation Scientific Retreat.