NCT06208280

F01 in the Treatment of Autoimmune Diseases

An Exploratory Clinical Study to Evaluate the Safety and Tolerability of F01 in the Treatment of Autoimmune Diseases

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open lable clinical study to evaluate the safety and tolerability of F01 in autoimmune diseases.

Detailed description

Approximately up to 20 participants with autoimmune diseases (including moderate-to-severe active systemic lupus erythematosus, relapse or refractory antineutrophil cytoplasmic antibody associated vasculitis,refractory idiopathic inflammatory myopathies and relapsed/refractory active diffuse cutaneous systemic sclerosis) are planned to enroll. This study is divided into two stages: dose escalation and dose extension.

Conditions

• Autoimmune Diseases

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-01-09
• Primary completion: 2025-01-01
• Completion: 2025-12-01
• First posted: 2024-01-17
• Last updated: 2024-01-17

Locations

1 site across 1 country: China