Testing ADI-001 in people with treatment-refractory rheumatoid arthritis
A Phase 1 Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma-Delta (γδ) T Cells in Adults With Treatment-refractory Rheumatoid Arthritis
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 |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Adicet Therapeutics Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07100873 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Adicet Clinical Trials — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Adicet Medical Monitor
- Email: lma@shanghaiadicet.cn
- Phone: 021-61673760
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.