Tests ADI-001 cell therapy in adults with hard-to-treat rheumatoid arthritis
Tests ADI-001 cell therapy, with two lymphodepletion regimens, in adults with rheumatoid arthritis.
Plain-language title generated from the registry record
Registry title: A Phase 1 Study of ADI-001 in Rheumatoid Arthritis
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07100873, who can take part
Where in China
- Adicet Clinical TrialsShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Adicet Therapeutics
- Trial code
- NCT07100873
- Record updated
- 8 December 2025
- Original description
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-upRead full original descriptionShow less
A Phase 1 Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma-Delta (γδ) T Cells in Adults With Treatment-refractory Rheumatoid Arthritis
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
Inclusion: ≥ 18 years of age; Fulfills the 2010 ACR-EULAR RA classification criteria; Agreement not to take traditional medicines and medications not prescribed by a doctor; Adequate hematological, liver, cardiac and pulmonary function.
Exclusion: 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; Presence of severe liver disease, Child-Pugh class B or C; Autoimmune disease requiring prednisone higher than 0.5 mg/kg/day (or corticosteroid equivalent); Subjects unwilling to participate in an extended safety monitoring period (LTFU protocol).