Rheumatoid Arthritis (RA)
Conditions
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
Interventions
DRUGADI-001
Anti-CD20 CAR-T
DRUGFludarabine
Chemotherapy for Lymphodepletion
DRUGCyclophosphamide
Chemotherapy for Lymphodepletion
Sponsors
Adicet Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactAdicet Medical Monitor
Outcome results
None listed