drugset / Trial / NCT05651178
Human CD19-CD22 Targeted T Cells Injection for Refractory/Relapsed Central Nervous System Leukemia/Lymphoma Patients
Phase 0
Active not recruiting
10 enrolled
Hrain Biotechnology Co., Ltd.
Second Affiliated Hospital of Nanchang University · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is a open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of Human CD19-CD22 Targeted T Cells by intravenous and intrathecal administration, and to preliminarily observe the efficacy of the trial drug in patients with central nervous system involvement of refractory/relapsed B cell malignancies.
Timeline
- Start
- 2022-08-12
- Primary completion
- 2024-11-30
- Completion
- 2027-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Human CD19-CD22 Targeted T Cells Injection | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | Human CD19-CD22 Targeted T Cells Injection | Cell therapy | 1e+06 cells | Intravenous |
| Subject | Human CD19-CD22 Targeted T Cells Injection | Cell therapy | 3e+06 cells/kg | Intravenous |
| Subject | Human CD19-CD22 Targeted T Cells Injection | Cell therapy | 5e+06 cells/kg | Intravenous |