drugset / Trial / NCT05170568

Summary

This is a Phase I, open-label, dose-escalation clinical study with the primary objective of evaluating the safety and tolerability of PA3-17 injection in adult subjects with CD7-positive relapsed/refractory lymphoid hematologic malignancies. The secondary objectives are as follows: to evaluate the proliferation and in vivo persistence of CD7-targeted chimeric antigen receptor T (CAR-T) cells after injection of PA3-17; to evaluate the proportion of CD7-positive cells in peripheral blood after injection of PA3-17; to preliminarily evaluate the efficacy of PA3-17 injection in adult subjects with CD7-positive relapsed/refractory lymphoid hematologic malignancies; to evaluate the immunogenicity of PA3-17 injection; and to explore the applicable dose in Phase II trial.

Timeline

Start
2021-12-01
Primary completion
2022-12-01
Completion
2024-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject PA3-17 Cell therapy 0.5 cells/kg —
Subject PA3-17 Cell therapy 2 cells/kg —
Subject PA3-17 Cell therapy 4 cells/kg —