drugset / Trial / NCT06367114
Clinical Trial of ssCART-19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (Including Central Nervous System Infiltration)
Phase 2
Unknown
50 enrolled
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Peking University People's Hospital · collabThe First Affiliated Hospital of Soochow University · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is a Phase II, single-arm, open-label, non-randomized, dose-escalation clinical trial to evaluate the efficacy and safety of ssCART-19 Cell Injection in the treatment of patients with CD19 positive Relapsed or Refractory acute lymphoblastic leukemia, including central nervous system infiltration.
Timeline
- Start
- 2024-04
- Primary completion
- 2024-09
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ssCART-19 | Cell therapy | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |