PA3-17 Injection in Adult Patients With CD7-positive Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma

Plain-language summary

This single-arm, open-label, multicenter Phase 2 study investigates PA3-17, a T-cell product carrying a chimeric antigen receptor targeting CD7. Eligible participants undergo a single nucleated cell collection for CAR-T manufacturing, receive lymphodepletion followed by one PA3-17 infusion, and give blood samples before and after infusion for pharmacokinetic, pharmacodynamic, immunogenicity and safety evaluation. Participants must be 18 or older with an ECOG score of 0-1, life expectancy of at least 3 months, and confirmed acute T-cell lymphoblastic leukemia/lymphoma (T-ALL/LBL) per the WHO fifth edition classification; efficacy is assessed up to 24 months after infusion.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Recruiting

Sponsor

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Intervention

T cell injection targeting CD7 chimeric antigen receptor

Start date

9/25/2025

Estimated completion

10/1/2027

Countries

China

Related genes

Locations

• Hefei, China
• Beijing, China
• Beijing, China
• Guangzhou, China
• Guangzhou, China
• Harbin, China
• Zhengzhou, China
• Zhengzhou, China
• Wuhan, China
• Nanjing, China
• Suzhou, China
• Xuzhou, China
• Shanghai, China
• Chengdu, China
• Tianjin, China
• Hangzhou, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.