NCT07100873

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Adicet Therapeutics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
DRUG	ADI-001	Anti-CD20 CAR-T
DRUG	Fludarabine	Chemotherapy for Lymphodepletion
DRUG	Cyclophosphamide	Chemotherapy for Lymphodepletion

Timeline

• Start date: 2025-10-10
• Primary completion: 2027-03-30
• Completion: 2028-03-30
• First posted: 2025-08-03
• Last updated: 2025-12-08

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study