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
1 other identifier
interventional
25
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2025
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2025
CompletedFirst Posted
Study publicly available on registry
August 3, 2025
CompletedStudy Start
First participant enrolled
October 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 30, 2028
December 8, 2025
December 1, 2025
1.5 years
July 28, 2025
December 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort
This primary endpoint will be used to evaluate safety and tolerability of AD1-001 in subjects with treatment-refractory RA
28 days
Study Arms (5)
Experimental: Run-in
EXPERIMENTALExperimental: Part 1a
EXPERIMENTALCy/Flu LD
Experimental: Part 1b
EXPERIMENTALCy-only LD
Experimental: Part 2a
EXPERIMENTALCy/Flu LD
Experimental: Part 2b
EXPERIMENTALCy-only LD
Interventions
Anti-CD20 CAR-T
Chemotherapy for Lymphodepletion
Chemotherapy for Lymphodepletion
Eligibility Criteria
You may qualify if:
- ≥ 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Adicet Clinical Trials
Shanghai, Shanghai Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2025
First Posted
August 3, 2025
Study Start
October 10, 2025
Primary Completion (Estimated)
March 30, 2027
Study Completion (Estimated)
March 30, 2028
Last Updated
December 8, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share