drugset / Trial / NCT05762510
A Study Evaluating the Safety and Efficacy of LentiRed Drug Product in Transfusion-dependent β-Thalassemia [TDT]
Phase 0
Recruiting
5 enrolled
First Affiliated Hospital of Guangxi Medical University
Genmedicn Biopharma Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a single-arm, open label, single-dose study in subjects with transfusion dependent β-thalassaemia. The study will evaluate the safety and efficacy of autologous CD34+ Human Hematopoietic Stem Cells that was transduced with LentiRed Lentivrial vector.
Timeline
- Start
- 2023-02-22
- Primary completion
- 2028-04-01
- Completion
- 2030-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GMCN-508B | Gene therapy (AAV / viral vector) | — | Intravenous |