Tests PA3-17 CAR-T cells in adults with relapsed CD7-positive T-cell leukemia or lymphoma
Tests PA3-17 CAR-T cell infusion in adults with relapsed or refractory CD7-positive T-lymphoblastic leukemia.
Plain-language title generated from the registry record
Registry title: PA3-17 Injection in Adult Patients With CD7-positive Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma
Key facts
- Where
- Beijing, Chengdu, Guangzhou, Hangzhou, Harbin, Hefei, Nanjing, Shanghai, Suzhou, Tianjin, Wuhan, Xuzhou, and Zhengzhou, ChinaSee the 16 sites
- Phase
- Phase 2
Where in China
- Peking University People's HospitalBeijing, ChinaTaking people
- Peking University Third HospitalBeijing, ChinaTaking people
- West China Hospital, Sichuan University (WCHSU)Chengdu, ChinaTaking people
- Facility Name: Guangdong Provincial People's HospitalGuangzhou, ChinaNot yet recruiting
- Sun Yat-sen University Cancer Center (SYSUCC)Guangzhou, ChinaTaking people
- The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaNot yet recruiting
- The First Hospital of HarbinHarbin, ChinaNot yet recruiting
- The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)Hefei, ChinaTaking people
- Jiangsu Province HospitalNanjing, ChinaTaking people
- Tongji Hospital Tongji UniversityShanghai, ChinaTaking people
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical SciencesTianjin, ChinaTaking people
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaTaking people
- The affiliated hospital of xuzhou medical universityXuzhou, ChinaTaking people
- Henan Cancer HospitalZhengzhou, ChinaTaking people
- The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Trial code
- NCT07188610
- Record updated
- 6 July 2026
- Original description
**Translation:**Read full original descriptionShow less
PA3-17 Injection for the Treatment of Subjects With Relapsed/Refractory T-Lymphoblastic Leukemia/Lymphoma: A Single-Arm, Open-Label Phase II Clinical Trial
**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.
Inclusion: Age and Gender: ≥18 years old (inclusive), regardless of gender; Survival Expectancy: ≥3 months; Performance Status: ECOG score 0-1; Diagnosis: Confirmed acute T-cell lymphoblastic leukemia/lymphoma (T-ALL/LBL) according to the WHO fifth edition of the "Classification of Hematopoietic and Lymphoid Tumors," including early T-cell precursor (ETP); Recurrent or Refractory Disease: Subjects with recurrent/refractory T-ALL/LBL (including ETP-ALL/LBL); Screening: Abnormal cells CD7 expression positive; Lesion Assessment: If the subject has only extramedullary lesions, they must have evaluable lesions; Meet the requirements of liver, kidney, heart, and lung functions; No Severe Mental Disorders; Informed Consent: Ability to understand the trial and signed informed consent form.
Exclusion: Subjects who have received CAR-T therapy or other gene-modified cell therapy before screening; Participation in other clinical studies within 1 month before screening (end date of the last application of unapproved innovative drugs); Known to have active or uncontrolled autoimmune diseases; History of malignant tumors other than T-ALL/LBL within the past 5 years, except for adequately treated cervical intraepithelial neoplasia, basal cell or squamous cell skin cancer, locally treated prostate cancer, and ductal carcinoma in situ of the breast after radical surgery; Positive test results for hepatitis B, hepatitis C, syphilis, etc; Severe heart disease; Unstable systemic diseases as judged by the investigator; Presence of active infection or uncontrollable infection requiring systemic treatment; Presence of GvHD; Pregnant or breastfeeding women, and female subjects planning to conceive within 2 years after cell infusion, or male subjects whose partners plan to conceive within 2 years after cell infusion; Evidence of central nervous system involvement at the time of subject screening; Situations judged by the investigator as not suitable for cell preparation; Other circumstances deemed unsuitable for enrollment by the investigator.