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PA3-17 Injection in Adult Patients With CD7-positive Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma
Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
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.
Official title: PA3-17 Injection for the Treatment of Subjects With Relapsed/Refractory T-Lymphoblastic Leukemia/Lymphoma: A Single-Arm, Open-Label Phase II Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-09-25
Completion Date
2027-10-01
Last Updated
2025-12-05
Healthy Volunteers
No
Interventions
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.
Locations (15)
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guangdong, China
The First Hospital of Harbin
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Tongji Hospital, Tongji University
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University (WCHSU)
Chengdu, Sichuan, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China