Status:
RECRUITING
PA3-17 Injection in Adult Patients With CD7-positive Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma
Lead Sponsor:
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Conditions:
CD7-positive Relapsed/Refractory T Lymphoblastic Leukemia/Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 co...
Eligibility Criteria
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
- Known to have active or uncontrolled autoimmune diseases;
- Presence of GvHD;
- 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;
- 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;
- 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);
- 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.
Key Trial Info
Start Date :
September 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07188610
Start Date
September 25 2025
End Date
October 1 2027
Last Update
December 5 2025
Active Locations (15)
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1
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China, 230000
2
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100000
3
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100000
4
Sun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guangdong, China, 510000