Clinical Trial

A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) in Autoimmune Disease

Enrolling by Invitation Phase 1
View on ClinicalTrials.gov →
Summary
ADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion, safety/efficacy study in patients with autoimmune disease. The study will consist of different periods including screening, lymphodepletion, treatment, and follow-up
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2024-04-17; most recent amendment 2026-03-18.
Status change: Recruiting → Enrolling by Invitation 2026-03-18
Status change: Not Yet Recruiting → Recruiting 2024-10-29
Trial Details
NCT Number NCT06375993
Lead Sponsor Adicet Therapeutics
Conditions Lupus Nephritis, Autoimmune Diseases, Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE), ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myopathies, Stiff Person Syndrome
Enrollment 180 participants
Start Date 2024-11-10
Primary Completion 2026-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-19