RecruitingPhase 2NCT07188610

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

Sponsor

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Enrollment

100 participants

Start Date

Sep 25, 2025

Study Type

INTERVENTIONAL

Conditions

CD7-positive Relapsed/Refractory T Lymphoblastic Leukemia/Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cell therapy called PA3-17 for adults with a type of blood cancer called T-cell leukemia or lymphoma (T-ALL/LBL) that has come back or stopped responding to prior treatment. The therapy targets a protein called CD7 found on the cancer cells. **You may be eligible if...** - You are 18 or older with confirmed T-cell leukemia or lymphoma - Your cancer has relapsed or not responded to at least one prior treatment - Your cancer cells test positive for CD7 protein - You have never received CAR-T cell therapy before - Your heart, liver, kidneys, and lungs are functioning well enough **You may NOT be eligible if...** - You have active or uncontrolled autoimmune disease - You have graft-versus-host disease (from a prior bone marrow transplant) - You have tested positive for hepatitis B, hepatitis C, or syphilis - You are pregnant, breastfeeding, or planning to have children within 2 years of treatment - You are currently participating in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALT 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07188610