NCT07188610

PA3-17 Injection in Adult Patients With CD7-positive Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma

PA3-17 Injection for the Treatment of Subjects With Relapsed/Refractory T-Lymphoblastic Leukemia/Lymphoma: A Single-Arm, Open-Label Phase II Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

\*\*Translation:\*\* This clinical trial is designed as a single-arm, open-label, multicenter study. After signing the informed consent form, eligible subjects will undergo a single nucleated cell collection for the preparation of CAR-T cells. Following lymphodepletion pretreatment, a single infusion of PA3-17 injection will be administered. Blood samples will be collected from the subjects before and after the infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety evaluations. In addition to the baseline period, the treatment phase will involve efficacy assessments at 4 weeks, 2 months, 3 months, and every 3 months thereafter, up to 24 months post-cell infusion. Tumor assessments will continue until disease progression (PD), initiation of new antitumor treatment, death, unacceptable toxicity, investigator decision, or subject's voluntary withdrawal, whichever occurs first.

Conditions

• CD7-positive Relapsed/Refractory T Lymphoblastic Leukemia/Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	T cell injection targeting CD7 chimeric antigen receptor	After signing the informed consent form, eligible subjects will undergo a single nucleated cell collection for the preparation of CAR-T cells, followed by lymphodepletion pretreatment and a single infusion of PA3-17 injection.

Timeline

• Start date: 2025-09-25
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2025-09-23
• Last updated: 2025-12-05

Locations

15 sites across 1 country: China