PA3-17 Injection Treatment of Adult Patients With CD7-positive Relapsed/Refractory Lymphoid Hematologic Malignancies
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |