F01 in the Treatment of Autoimmune Diseases
NCT06208280 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2024-01-17
Summary
This is a multicenter, open lable clinical study to evaluate the safety and tolerability of F01 in autoimmune diseases.
Conditions
Interventions
- DRUG
-
After preconditioning with Fludarabine and Cyclophosphamide, F01 will be evaluated.
Drug: After preconditioning with Fludarabine and Cyclophosphamide, F01 will be evaluated. Biological: 0.5-3×10\^9 CAR+NK Cells, Treatment follows a lymphodepletion Drug: Fludarabine: 25-30 mg/m\^2 (D-5\~D-3) Drug: Cyclophosphamide: 250-300 mg/ m\^2 (D-5\~D-3)
Sponsors & Collaborators
-
Shanghai Simnova Biotechnology Co.,Ltd.
collaborator INDUSTRY -
RenJi Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-09
- Primary Completion
- 2025-01-31
- Completion
- 2025-12-31
Countries
- China
Study Locations
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