drugset / Trial / NCT06468683
F01 in the Treatment of Moderate-to-severe Refractory Systemic Lupus Erythematosus
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-06-15
- Primary completion
- 2027-01-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | F01 | Cell therapy | 5e+08 cells | — |
| Subject | F01 | Cell therapy | 3e+09 cells | — |
| Background | Cyclophosphamide | Other / unclassified | 250 mg/m2 | — |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | — |
| Background | Fludarabine | Small molecule | 25 mg/m2 | — |
| Background | Fludarabine | Small molecule | 30 mg/m2 | — |