Trials / Enrolling By Invitation
Enrolling By InvitationNCT06375993
A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) in Autoimmune Disease
A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) Anti-CD20 CAR-engineered Allogeneic Gamma-Delta (γδ) T Cells in Adults With Autoimmune Disease
- Status
- Enrolling By Invitation
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- Sponsor
- Adicet Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Conditions
- Lupus Nephritis
- Autoimmune Diseases
- Systemic Sclerosis (SSc)
- Systemic Lupus Erythematosus (SLE)
- ANCA-Associated Vasculitis (AAV)
- Idiopathic Inflammatory Myopathies
- Stiff Person Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ADI-001 | Anti-CD20 CAR-T |
| DRUG | Fludarabine | Chemotherapy for Lymphodepletion |
| DRUG | Cyclophosphamide | Chemotherapy for Lymphodepletion |
Timeline
- Start date
- 2024-11-10
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
- First posted
- 2024-04-19
- Last updated
- 2026-03-19
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06375993. Inclusion in this directory is not an endorsement.