drugset / Trial / NCT06920199
Treatment of Refractory cGVHD by Donor-derived Treg Cell Injection Combined With Recombinant Human Interleukin-2
Phase 0
Recruiting
18 enrolled
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
NaSingle-groupOpen-labelTreatment
Summary
This study is a single-arm, open-label, dose-escalation clinical trial to evaluate the safety, tolerability, changes and persistence of peripheral blood Treg cells, and pharmacodynamic characteristics of donor-derived Treg cell injection combined with recombinant human interleukin-2 in treating subjects with refractory cGVHD，and to preliminarily observe the efficacy of the study drugs in subjects with refractory cGVHD.
Timeline
- Start
- 2025-06-14
- Primary completion
- 2027-05-15
- Completion
- 2027-09-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Donor-derived Treg cell injection | Cell therapy | 1e+06 cells/kg | — |
| Subject | Donor-derived Treg cell injection | Cell therapy | 5e+06 cells/kg | — |
| Subject | Donor-derived Treg cell injection | Cell therapy | 1e+07 cells/kg | — |
| Subject | aldesleukin | Protein / enzyme biologic | 1e+06 unknown | Subcutaneous |