RECRUITINGPhase 1INTERVENTIONAL
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
About This Trial
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
Who May Be Eligible (Plain English)
Who May Qualify:
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
Who Should NOT Join This Trial:
1. Presence of severe liver disease, Child-Pugh class B or C.
2. autoimmune conditions (where your immune system attacks your own body) 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
ADI-001
Anti-CD20 CAR-T
DRUG
Fludarabine
Chemotherapy for Lymphodepletion
DRUG
Cyclophosphamide
Chemotherapy for Lymphodepletion
Locations (1)
Adicet Clinical Trials
Shanghai, Shanghai Municipality, China