Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
25 participants
INTERVENTIONAL
2025-10-10
2028-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental: Run-in
ADI-001
Anti-CD20 CAR-T
Fludarabine
Chemotherapy for Lymphodepletion
Cyclophosphamide
Chemotherapy for Lymphodepletion
Experimental: Part 1a
Cy/Flu LD
ADI-001
Anti-CD20 CAR-T
Fludarabine
Chemotherapy for Lymphodepletion
Cyclophosphamide
Chemotherapy for Lymphodepletion
Experimental: Part 1b
Cy-only LD
ADI-001
Anti-CD20 CAR-T
Cyclophosphamide
Chemotherapy for Lymphodepletion
Experimental: Part 2a
Cy/Flu LD
ADI-001
Anti-CD20 CAR-T
Fludarabine
Chemotherapy for Lymphodepletion
Cyclophosphamide
Chemotherapy for Lymphodepletion
Experimental: Part 2b
Cy-only LD
ADI-001
Anti-CD20 CAR-T
Cyclophosphamide
Chemotherapy for Lymphodepletion
Interventions
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ADI-001
Anti-CD20 CAR-T
Fludarabine
Chemotherapy for Lymphodepletion
Cyclophosphamide
Chemotherapy for Lymphodepletion
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Adicet Therapeutics
INDUSTRY
Responsible Party
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Locations
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Adicet Clinical Trials
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ADI-001-106
Identifier Type: -
Identifier Source: org_study_id
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