NCT06468683

F01 in the Treatment of Moderate-to-severe Refractory Systemic Lupus Erythematosus

A Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of F01 in Patients With Moderate-to-severe Refractory Systemic Lupus Erythematosus

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Shanghai Simnova Biotechnology Co.,Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I clinical study to evaluate the safety , pharmacokinetic profile, and preliminary efficacy of F01 in patients with moderate-to-severe refractory systemic lupus erythematosus.

Detailed description

Approximately up to about 50 participants with moderate-to-severe refractory systemic lupus erythematosus are planned to enroll. This study is divided into two stages: dose escalation and dose extension.

Conditions

• Lupus Erythematosis

Interventions

Type	Name	Description
BIOLOGICAL	After preconditioning with chemotherapy, 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: 2024-06-15
• Primary completion: 2027-01-31
• Completion: 2027-12-31
• First posted: 2024-06-21
• Last updated: 2024-06-21

Locations

1 site across 1 country: China