A Phase 1 Study of ADI-001 in Rheumatoid Arthritis

Not Applicable

Not yet recruiting

• Conditions: Rheumatoid Arthritis (RA)
• Interventions: Drug: ADI-001; Drug: Fludarabine; Drug: Cyclophosphamide

• Registration Number: NCT07100873
• Lead Sponsor: Adicet Therapeutics

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-28
• Study First Submitted QC: 2025-07-28
• Last Update Submitted: 2025-07-28
• Study First Posted: 2025-08-03
• Last Update Posted: 2025-08-03
• Study Start: 2025-08-15
• Primary Completion: 2027-03-30
• Study Completion: 2028-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Run-in	ADI-001	-
Experimental: Run-in	Fludarabine	-
Experimental: Run-in	Cyclophosphamide	-
Experimental: Part 1a	ADI-001	Cy/Flu LD
Experimental: Part 1a	Fludarabine	Cy/Flu LD
Experimental: Part 2a	ADI-001	Cy/Flu LD
Experimental: Part 1a	Cyclophosphamide	Cy/Flu LD
Experimental: Part 1b	ADI-001	Cy-only LD
Experimental: Part 1b	Cyclophosphamide	Cy-only LD
Experimental: Part 2a	Cyclophosphamide	Cy/Flu LD
Experimental: Part 2b	ADI-001	Cy-only LD
Experimental: Part 2b	Cyclophosphamide	Cy-only LD
Experimental: Part 2a	Fludarabine	Cy/Flu LD

Primary Outcome Measures

Name	Time	Method
The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort	28 days	This primary endpoint will be used to evaluate safety and tolerability of AD1-001 in subjects with treatment-refractory RA

Trial Locations

Locations (1)

Adicet Clinical Trials; 🇨🇳 Shanghai, Shanghai, China