Clinical trial

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

Name

ADI-202300103

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 arms

Trial start

2024-06-01

Estimated PCD

2026-12-01

Trial end

2027-12-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

ADI-001

Anti-CD20 CAR-T

Arms:

ADI-001 Dose Escalation, ADI-001 Dose Expansion, ADI-001 Dose Extension

Fludarabine

Chemotherapy for Lymphodepletion

Arms:

ADI-001 Dose Escalation, ADI-001 Dose Expansion, ADI-001 Dose Extension

Cyclophosphamide

Chemotherapy for Lymphodepletion

Arms:

ADI-001 Dose Escalation, ADI-001 Dose Expansion, ADI-001 Dose Extension

Size

Primary endpoint

The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort

Day 42

Proportion of treatment emergent and treatment related adverse events

2 year

Eligibility criteria

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 \[INS\]/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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '3+3 Dose Escalation Design', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2024-04-19

1 organization

3 products

2 indications

Organization

Product

Indication

Indication

Product

Product