PA3-17 (CD7-targeted CAR-T) injection for adults with CD7-positive relapsed/refractory T-lymphoblastic leukemia/lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting
• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting

Study contacts

• Study coordinator: Xiaojun Huang, MD
• Email: xjhrm@medmail.com.cn
• Phone: +86-13701389625

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.