A Phase 1 Study of ADI-001 in Rheumatoid Arthritis
NCT07100873 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2025-12-08
Summary
ADI-001-106 is a phase 1 study of ADI-001 with a randomized, single-blind, parallel group design to compare two different LD regimens in subjects with treatment-refractory RA. The study will consist of different periods including screening, LD, treatment, and follow-up
Conditions
- Rheumatoid Arthritis (RA)
Interventions
- DRUG
-
ADI-001
Anti-CD20 CAR-T
- DRUG
-
Chemotherapy for Lymphodepletion
- DRUG
-
Chemotherapy for Lymphodepletion
Sponsors & Collaborators
-
Adicet Therapeutics
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-10
- Primary Completion
- 2027-03-30
- Completion
- 2028-03-30
- FDA Drug
- Yes
Countries
- China
Study Locations
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