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

NCT07623681 ↗

Phase 1 Not yet recruiting 12 enrolled PersonGen BioTherapeutics (Suzhou) Co., Ltd.
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

EvaluationDrugModalityDoseRoute
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 —