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

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

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing ADI-001 — a type of engineered immune cell therapy using gamma delta T cells — as a potential treatment for rheumatoid arthritis (RA), an autoimmune condition that causes painful, swollen joints. This is the first time ADI-001 is being tested in people with RA. **You may be eligible if...** - You are 18 or older - You have been diagnosed with rheumatoid arthritis based on established international criteria - Your liver, heart, blood, and lung function are adequate - You are willing not to take traditional medicines or unprescribed medications during the study - You agree to participate in an extended long-term safety follow-up **You may NOT be eligible if...** - You have severe liver disease (Child-Pugh class B or C) - You need high-dose corticosteroids (prednisone >0.5 mg/kg/day) to control your autoimmune condition - You have had a significant infection (including sepsis, pneumonia, or fungal infection) in the past 4 weeks - You are unwilling to complete the long-term follow-up monitoring period Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGADI-001

Anti-CD20 CAR-T

DRUGFludarabine

Chemotherapy for Lymphodepletion

DRUGCyclophosphamide

Chemotherapy for Lymphodepletion


Locations(1)

Adicet Clinical Trials

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07100873


Related Trials