CD19-targeted CAR-T cells that make p40 for relapsed or refractory CD19-positive blood cancers

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 is a single-arm Phase 1/2 trial testing an autologous CD19-directed CAR-T product engineered to express autocrine p40 to enhance expansion and persistence. Eligible patients undergo leukapheresis for manufacture of CD19-CAR.p40-T cells, receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, and then a single intravenous CAR-T infusion. Participants are closely monitored for safety including cytokine release syndrome and neurotoxicity, and disease response is measured using standard disease-specific criteria. Serial blood samples will track CAR-T cell expansion, persistence, and pharmacokinetic/cellular-kinetic profiles.

Why it matters

Who can join: the full rules

Inclusion Criteria

Subjects must meet all of the following criteria to be enrolled:

1. • Aged 18 to 75 years, male or female;
2. • Histologically or cytologically diagnosed with relapsed/refractory CD19-positive hematologic malignancy according to the 2022 World Health Organization (WHO) diagnostic criteria;
3. • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
4. • Life expectancy of at least 3 months;
5. • No contraindications to peripheral blood leukapheresis;
6. • CD19 expression on tumor cells confirmed by flow cytometry and/or immunohistochemistry;
7. • No severe cardiac, pulmonary, hepatic, or renal dysfunction;
8. • Able to understand and willing to provide written informed consent. Exclusion Criteria

Subjects who meet any of the following criteria should be excluded from enrollment:

1. History of allergy to any component of the cellular product;
2. Complete blood count meeting any of the following criteria: white blood cell count (WBC) ≤1 × 10⁹/L, absolute neutrophil count (ANC) ≤0.5 × 10⁹/L, absolute lymphocyte count (ALC) ≤0.5 × 10⁹/L, or platelet count (PLT) ≤25 × 10⁹/L;
3. Laboratory abnormalities including, but not limited to, serum total bilirubin ≥1.5 mg/dL; serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 times the upper limit of normal; or serum creatinine ≥2.0 mg/dL;
4. Class III or IV cardiac insufficiency according to the New York Heart Association (NYHA) functional classification, or left ventricular ejection fraction (LVEF) \<50% by echocardiography;
5. Abnormal pulmonary function, with oxygen saturation \<92% on room air;
6. History of myocardial infarction, cardiac angioplasty or stent placement, unstable angina, or other clinically significant severe cardiac disease within 12 months prior to enrollment;
7. Grade 3 hypertension with poor blood pressure control despite medication;
8. History of traumatic brain injury, disturbance of consciousness, epilepsy, severe cerebral ischemia, or cerebral hemorrhagic disease;
9. Autoimmune disease, immunodeficiency, or other conditions requiring treatment with immunosuppressive agents;
10. Uncontrolled active infection;
11. Prior treatment with any CAR-T cell product or other genetically modified T-cell therapy;
12. Receipt of a live vaccine within 4 weeks prior to enrollment;
13. Positive test results for HIV, HBV, HCV, or TPPA/RPR, or HBV carrier status;
14. History of alcohol abuse, drug abuse, or psychiatric illness;
15. Participation in any other clinical study within 3 months prior to enrollment in this clinical study;
16. Female subjects who meet any of the following conditions:

    1. Pregnant or breastfeeding;
    2. Planning to become pregnant during the study; or
    3. Of childbearing potential and unwilling or unable to use effective contraception;
17. Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in this study.

Where it's running

• Shenzhen University General Hospital
  Shenzhen, Other (Non U.s.), China Recruiting

Study contacts

• Principal investigator: lixin wang, PHD — Shenzhen University General Hospital
• Study coordinator: lixin wang, PHD
• Email: wanglixin1991@sohu.com
• Phone: 0755-21839999

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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.