Testing ADI-001 in people with treatment-refractory rheumatoid arthritis
Official title: A Phase 1 Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma-Delta (γδ) T Cells in Adults With Treatment-refractory Rheumatoid Arthritis
Run by Adicet Therapeutics · NCT07100873 · Data updated 2026-11-12
This Phase 1 test will try ADI-001 with two different pre-treatment (lymphodepletion) regimens in adults whose rheumatoid arthritis has not improved with standard therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Adicet Therapeutics Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | October 10, 2025 |
| Main results expected | March 30, 2027 |
| Study ends | March 30, 2028 |
| Registry record updated | December 8, 2025 |
| Trial ID | NCT07100873 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) who meet the 2010 ACR-EULAR RA criteria, have disease refractory to standard treatments, have adequate blood, liver, cardiac and lung function, and agree to lymphodepletion and extended safety follow-up are the ideal candidates.
✕Probably not a fit
People with severe liver disease (Child-Pugh B or C), those requiring high-dose corticosteroids, those with recent clinically significant infections, or those unwilling to undergo long-term safety monitoring are unlikely to be eligible or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, single-blind, parallel-group Phase 1 trial that compares two different lymphodepletion regimens given before ADI-001 in adults with treatment-refractory rheumatoid arthritis. The trial includes screening, a lymphodepletion (LD) period using agents such as fludarabine and cyclophosphamide, administration of ADI-001, and a follow-up/safety monitoring period. The primary focus is early safety and tolerability and to compare the two LD approaches; efficacy signals will be exploratory. The study is sponsored by Adicet Therapeutics and conducted at a single site in Shanghai.
Why it matters
Potential benefit: If successful, ADI-001 could provide a new treatment option for people with rheumatoid arthritis that has not responded to existing therapies.
How similar studies have gone: Lymphodepletion followed by cellular immunotherapies has shown promising signals in early trials for some autoimmune conditions, but this strategy remains experimental in RA with limited published efficacy data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ≥ 18 years of age. 2. Fulfills the 2010 ACR-EULAR RA classification criteria 3. Agreement not to take traditional medicines and medications not prescribed by a doctor 4. Adequate hematological, liver, cardiac and pulmonary function Exclusion Criteria: 1. Presence of severe liver disease, Child-Pugh class B or C. 2. Autoimmune disease requiring prednisone higher than 0.5 mg/kg/day (or corticosteroid equivalent). 3. Subjects unwilling to participate in an extended safety monitoring period (LTFU protocol) 4. History of a clinically significant infection (including sepsis, pneumonia, bacteremia, fungal, viral and opportunistic infections) within 4 weeks prior to first dose of study drug which in the opinion of the Investigator may compromise the safety of the subject in the study.
Where it's running
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Adicet Clinical Trials
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Adicet Medical Monitor
- Email: lma@shanghaiadicet.cn
- Phone: 021-61673760
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.