PA3-17 (CD7-targeted CAR-T) injection for adults 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

This will test a single infusion of PA3-17, a CD7-targeted CAR-T, in adults with CD7-positive relapsed or refractory T-lymphoblastic leukemia/lymphoma.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd. (Industry-sponsored)
• Drugs / interventions: CAR-T
• Locations: 15 sites (Hefei, Anhui and 14 other locations)
• Trial ID: NCT07188610 on ClinicalTrials.gov

What this trial studies

This single-arm, open-label, multicenter Phase 2 trial collects a single leukapheresis sample to manufacture PA3-17 CAR-T cells, administers lymphodepleting chemotherapy, and gives one CAR-T infusion. Blood will be sampled before and after infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety analyses. Efficacy assessments occur at 4 weeks, 2 months, 3 months, and then every 3 months up to 24 months, with tumor evaluations continued until progression or a predefined stopping event. The trial is conducted at multiple hospitals in China and enrolls adults with confirmed CD7-positive relapsed/refractory T-ALL/LBL.

Who should consider this trial

Good fit: Adults (≥18 years) with confirmed CD7-positive relapsed or refractory T-ALL/LBL, ECOG 0–1, expected survival ≥3 months, adequate organ function, and capacity to consent are ideal candidates.

Not a fit: Patients without CD7 expression, with active uncontrolled autoimmune disease or graft-versus-host disease, poor performance status, or inadequate organ function are unlikely to benefit.

Why it matters

Potential benefit: If successful, PA3-17 could induce meaningful remissions in patients with relapsed or refractory CD7-positive T-ALL/LBL.

How similar studies have performed: Early-phase CD7-targeted CAR-T trials have reported promising remission rates in small cohorts, but the approach remains experimental with limited follow-up.

Eligibility criteria

Inclusion Criteria:

1. Age and Gender: ≥18 years old (inclusive), regardless of gender.
2. Survival Expectancy: ≥3 months.
3. Performance Status: ECOG score 0-1.
4. 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).
5. Recurrent or Refractory Disease: Subjects with recurrent/refractory T-ALL/LBL (including ETP-ALL/LBL).
6. Screening: Abnormal cells CD7 expression positive.
7. Lesion Assessment: If the subject has only extramedullary lesions, they must have evaluable lesions.
8. Meet the requirements of liver, kidney, heart, and lung functions.
9. No Severe Mental Disorders.
10. Informed Consent: Ability to understand the trial and signed informed consent form.

Exclusion Criteria:

1. Known to have active or uncontrolled autoimmune diseases;
2. Presence of GvHD;
3. 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;
4. Positive test results for hepatitis B, hepatitis C, syphilis, etc.;
5. Severe heart disease;
6. Unstable systemic diseases as judged by the investigator;
7. Presence of active infection or uncontrollable infection requiring systemic treatment;
8. 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;
9. Subjects who have received CAR-T therapy or other gene-modified cell therapy before screening;
10. Participation in other clinical studies within 1 month before screening (end date of the last application of unapproved innovative drugs);
11. Evidence of central nervous system involvement at the time of subject screening;
12. Situations judged by the investigator as not suitable for cell preparation;
13. Other circumstances deemed unsuitable for enrollment by the investigator.

Where this trial is running

Hefei, Anhui and 14 other locations

• The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) — Hefei, Anhui, China (Recruiting)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Sun Yat-sen University Cancer Center (SYSUCC) — Guangzhou, Guangdong, China (Recruiting)
• The First Hospital of Harbin — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Recruiting)
• Tongji Hospital, Tongji University — Shanghai, Shanghai Municipality, China (Recruiting)
• West China Hospital, Sichuan University (WCHSU) — Chengdu, Sichuan, China (Recruiting)
• Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China (Recruiting)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Xiaojun Huang, MD

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