A Phase 1 Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma-Delta (γδ) T Cells in Adults With Treatment-refractory Rheumatoid Arthritis
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Adicet Therapeutics
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥ 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 Criteria
- •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.
Arms & Interventions
Experimental: Run-in
Intervention: Fludarabine (Drug)
Experimental: Run-in
Intervention: Cyclophosphamide (Drug)
Experimental: Part 1a
Cy/Flu LD
Intervention: ADI-001 (Drug)
Experimental: Part 1a
Cy/Flu LD
Intervention: Fludarabine (Drug)
Experimental: Part 1a
Cy/Flu LD
Intervention: Cyclophosphamide (Drug)
Experimental: Part 1b
Cy-only LD
Intervention: ADI-001 (Drug)
Experimental: Part 1b
Cy-only LD
Intervention: Cyclophosphamide (Drug)
Experimental: Part 2a
Cy/Flu LD
Intervention: ADI-001 (Drug)
Experimental: Part 2a
Cy/Flu LD
Intervention: Fludarabine (Drug)
Experimental: Part 2a
Cy/Flu LD
Intervention: Cyclophosphamide (Drug)
Experimental: Part 2b
Cy-only LD
Intervention: ADI-001 (Drug)
Experimental: Part 2b
Cy-only LD
Intervention: Cyclophosphamide (Drug)
Experimental: Run-in
Intervention: ADI-001 (Drug)
Outcomes
Primary Outcomes
The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort
Time Frame: 28 days
This primary endpoint will be used to evaluate safety and tolerability of AD1-001 in subjects with treatment-refractory RA
Secondary Outcomes
No secondary outcomes reported