RecruitingPhase 1NCT07100873

A Phase 1 Study of ADI-001 in 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

Sponsor

Adicet Therapeutics

Enrollment

25 participants

Start Date

Oct 10, 2025

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis (RA)

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

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

≥ 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 Criteria4

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)
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.