A Phase 1 Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma-Delta (γδ) T Cells in Adults with Lupus Nephritis

Description

ADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion safety/efficacy study in patients with lupus nephritis. The study will consist of different periods including screening, lymphodepletion, treatment, and follow-up

Trial Eligibility

Inclusion Criteria: 1. Clinical diagnosis of systemic lupus erythematosus (SLE) per 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria (Aringer 2019). 2. Active kidney disease with biopsy-proven active LN Class III or IV (coexistent class V permitted) (per 2018 International Society of Nephrology \[ISN\]/Renal Pathology Society \[RPS\] criteria) ; biopsy should be performed within 6 months before enrolling in the study. 3. ECOG performance ≤ 2 4. Proteinuria (or urine protein creatinine ratio \[UPCR\]) \> 1g / 24 hours. Exclusion Criteria: 1. LN pure class V, per 2018 ISN/RPS criteria (Bajema 2018). 2. Presence of severe liver disease, Child-Pugh class B or C. 3. Presence of autoimmune diseases other than SLE as the main diagnosis 4. Current or history of severe central nervous system involvement. 5. Presence of kidney impairment due to etiologies other than LN . 6. Prior treatment with any gene therapy, genetically modified cell therapy, or adoptive T cell therapy.

Study Info

Interventions

Locations Recruiting

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