Lupus nephritis (LN), systemic lupus erythematosus (SLE) and SSc
ACETAdicet BioCatalyst overview
Research summary
This catalyst tracks a Phase 1 data readout for ADI-001 (allogeneic CAR gamma-delta T cell therapy) in Lupus nephritis (LN), systemic lupus erythematosus (SLE) and SSc. The expected timing is based on the latest available company guidance and may change.
11/18/24- Ongoing enrollment for LN. 5/6/25- SLE, SSc, IIM, ANCA, AAV, & SPS enrollment in Q3 2025. 7/24/25- First SSc patient dosed. 10/7/25 - Ph1 lupus readout showing 7/7 responded and OK AEs. FDA meeting to inform trial design in Q1 2026; Ph2 initiation by Q2 2026. 11/05/25:- Detailed positive Ph1 LN/SLE data; FDA meeting Q1 2026; Ph2 start Q2 2026; LN/SLE/SSc update H1 2026. 03/12/26:- Fast Track, outpatient LN/SLE; Ph1 clinical updates H1 and H2 2026; FDA meeting Q2 2026; pivotal H2 2026. 05/13/26:- Phase 1 prula-cel LN/SLE update expected mid-2026; SSc update H2 2026; FDA meeting Q2 2026; pivotal start H2 2026. 08/05/26:- LN/SLE Ph1 data Q3 2026; SSc update and pivotal startup H2 2026.
Verification
Confirm timing and program details against the company announcement or filing.