Actively Recruiting
A Phase 1 Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma-Delta T Cells in Adults With Treatment-refractory Rheumatoid Arthritis
Led by Adicet Therapeutics · Updated on 2025-12-08
25
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a phase 1 clinical trial to study ADI-001, an Anti-CD20 CAR-engineered allogeneic gamma-delta T cell therapy, in adults with treatment-refractory Rheumatoid Arthritis (RA). The trial aims to compare two different lymphodepletion regimens to assess safety and dose-limiting toxicities in participants whose RA has not responded to standard treatments. This study uses a randomized, single-blind, parallel group design to evaluate these approaches. The study involves several treatment periods including screening, lymphodepletion (LD), treatment with ADI-001, and follow-up. Participants are assigned to one of two lymphodepletion regimens: a combination of cyclophosphamide and fludarabine (Cy/Flu LD) or cyclophosphamide alone (Cy-only LD). The trial consists of experimental phases labeled as Run-in, Part 1a, Part 1b, Part 2a, and Part 2b, each assessing different aspects of the treatment process. Participants will undergo assessments throughout the study to monitor safety, including laboratory tests and evaluations of vital organ function. Researchers will specifically measure the incidence of dose-limiting toxicities within 28 days after dosing. The trial includes extended safety monitoring to ensure participant well-being during and after treatment. The overall duration and detailed follow-up procedures are structured to comprehensively evaluate treatment effects and safety.
CONDITIONS
Brief Title
A Phase 1 Study of ADI-001 in Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Meets the 2010 ACR-EULAR classification criteria for rheumatoid arthritis
- Agree not to take traditional medicines or medications not prescribed by a doctor
- Adequate hematological, liver, cardiac, and pulmonary function
You will not qualify if you...
- Severe liver disease classified as Child-Pugh class B or C
- Autoimmune disease requiring prednisone higher than 0.5 mg/kg/day or corticosteroid equivalent
- Unwillingness to participate in extended safety monitoring (long-term follow-up protocol)
- History of clinically significant infection within 4 weeks before first study drug dose, including sepsis, pneumonia, bacteremia, fungal, viral, or opportunistic infections
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Short period prior to treatment (exact duration per protocol)
Participants receive chemotherapy with Cyclophosphamide and Fludarabine for lymphodepletion before CAR-T cell treatment.
1 to 2 visits depending on cohort assignment
Duration - 28 days or per dose level cohort until dose-limiting toxicity or discontinuation
Participants receive ADI-001 Anti-CD20 CAR-engineered allogeneic gamma-delta T cells as active treatment for rheumatoid arthritis.
Multiple visits during treatment period as per protocol
Duration - Up to several months following treatment
Participants are monitored for safety and treatment effects after completion of active treatment.
Approximately weekly visits for up to 28 days post-treatment
Trial Site Locations
Total: 1 location
1
Adicet Clinical Trials
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
A
Adicet Medical Monitor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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