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NCT06375993 Clinical Trial

A Phase 1 Study of ADI-001 in Lupus Nephritis

Autoimmune Diseases Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06375993
Other study ID # ADI-202300103
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date June 2024
Est. completion date December 2027

Study information
Verified date April 2024
Source Adicet Bio, Inc
Contact Adicet Medical Director
Phone 650-503-9095
Email clinicaltrials@adicetbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date December 2027
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
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 [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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Adicet Bio, Inc

Outcome
Type Measure Description Time frame Safety issue
Primary The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort This primary endpoint will be used to determine the Maximum Tolerated Dose (MTD) or Maximum Assessed dose (MAD) Day 42
Primary Proportion of treatment emergent and treatment related adverse events This primary endpoint will be used to determine the MTD/MAD of ADI-001 2 year
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