Clinical Trial

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

Recruiting Phase 2
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-09-16; most recent amendment 2026-07-02.
Status change: Not Yet Recruiting → Recruiting 2025-12-04
Trial Details
NCT Number NCT07188610
Lead Sponsor PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Conditions CD7-positive Relapsed/Refractory T Lymphoblastic Leukemia/Lymphoma
Enrollment 100 participants
Start Date 2025-09-25
Primary Completion 2026-10-01 (estimated)
Study Completion 2027-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-06