drugset / Trial / NCT07623681
Single-arm, Open-label, Dose-escalating Phase I Clinical Study of PA3-17 Injection in Children and Adolescents With Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma
NaSingle-groupOpen-labelTreatment
Summary
This is a phase I, open-label, dose-escalation clinical trial. The primary objectives are to assess the safety of PA3-17 injection in pediatric and adolescent participants with relapsed/refractory T-lymphoblastic leukemia/lymphoma, and determine the recommended phase II dose of PA3-17 injection for this patient population. Secondary objectives include evaluating the pharmacokinetics/pharmacodynamics, preliminarily assessing clinical efficacy, and evaluating the immunogenicity of the injection.
Timeline
- Start
- 2026-06-10
- Primary completion
- 2026-06-30
- Completion
- 2028-07-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PA3-17 | Cell therapy | 1e+06 cells/kg | — |
| Subject | PA3-17 | Cell therapy | 2e+06 cells/kg | — |
| Subject | PA3-17 | Cell therapy | 4e+06 cells/kg | — |