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

Adicet Therapeutics

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

Eligibility

Age range: 18–80 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: For Cohort 1: Subjects with LN: * Clinical diagnosis of systemic lupus erythematosus (SLE) per 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria (Aringer 2019). * Have unequivocally positive anti-nuclear antibody (ANA) test results defined as an ANA titer ≥ 1:80 (based on Hep-2 immunofluorescence assay or equivalence by enzyme-linked immunosorbent assay (ELISA), and/or positive anti-dsDNA (≥ 30 IU/mL based on ELISA. * Historical ANA and anti-dsDNA results (defined as within the 2 years prior to enrollment) may b…

Interventions

Drug
ADI-001
Anti-CD20 CAR-T
Drug
Fludarabine
Chemotherapy for Lymphodepletion
Drug
Cyclophosphamide
Chemotherapy for Lymphodepletion

Locations (2)

Adicet Clinical Trials
Redwood City, California
Roswell Park Comprehensive Cancer Center
Buffalo, New York

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

Summary

Eligibility

Interventions

Locations (2)

Compensation

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Details

Conditions