Autocrine p40 CD19/CD20 dual-targeting CAR-T therapy for relapsed or refractory B-cell 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 Phase I/IIa interventional trial will enroll about 20 adults with relapsed or refractory B-cell lymphoma to receive a single intravenous infusion of autocrine p40 CAR-T cells targeting CD19/CD20 (total dose 0.5–2×10^6 CAR-T cells/kg) after lymphodepleting chemotherapy (fludarabine + cyclophosphamide). Eligible patients are assigned by the investigator to receive either the dual-targeting CD19/CD20 CAR.p40-T or a CD19-only CAR.p40-T product, with safety (treatment-emergent adverse events within 30 days) as the primary endpoint. Secondary endpoints include objective response rate within 8 weeks, six-month overall and progression-free survival, and in vivo CAR-T expansion and persistence. The trial includes standard pre-infusion apheresis and hospital-based monitoring for cytokine release syndrome and other CAR-T–related toxicities.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged between 15 and 75 years old, regardless of gender;
2. Diagnosed with relapsed/refractory B-cell lymphoma according to the 2020 World Health Organization (WHO) diagnostic criteria;
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
4. Expected survival time of ≥ 3 months;
5. Confirmation of CD20 expression in tumor cells by flow cytometry/immunohistochemistry;
6. Patients tolerant to CD19 CAR-T cell therapy or those with low CD19 expression;
7. No severe heart, lung, liver, or kidney diseases;
8. Capable of understanding and willing to sign the informed consent form for this trial;
9. No contraindications to peripheral blood apheresis for the subject;
10. Having clearly measurable and evaluable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard;
11. The subject must have received standard first- and second-line treatment regimens;
12. Not having received antibody-based drug treatment within 2 weeks before cell therapy.

Exclusion Criteria:

1. History of allergy to any component in the cell product;
2. The following conditions in the blood routine examination: White blood cell count (WBC) ≤ 1×10⁹/L, absolute neutrophil count (ANC) ≤ 0.5×10⁹/L, absolute lymphocyte count (ALC) ≤ 0.5×10⁹/L, platelet count (PLT) ≤ 25×10⁹/L;
3. The following conditions in laboratory tests: including but not limited to, total serum bilirubin ≥ 1.5 mg/dl; serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the upper limit of normal; serum creatinine ≥ 2.0 mg/dl;
4. Patients with heart failure classified as grade III or IV according to the New York Heart Association (NYHA) classification criteria; or left ventricular ejection fraction (LVEF) \< 50% as detected by echocardiography;
5. Abnormal lung function with oxygen saturation \< 92% under room air;
6. Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically severe heart diseases within 12 months before enrollment;
7. Grade 3 hypertension with poorly controlled blood pressure despite drug treatment;
8. History of craniocerebral trauma, disturbance of consciousness, epilepsy, severe cerebral ischemia or intracerebral hemorrhagic diseases;
9. Patients with autoimmune diseases, immunodeficiency, or other conditions requiring immunosuppressive agent treatment;
10. Presence of uncontrolled active infection;
11. Previous use of any CAR-T cell product or other genetically modified T cell therapies;
12. Vaccination with live vaccines within 4 weeks before enrollment;
13. Subjects positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and Treponema pallidum particle agglutination assay (TPPA)/rapid plasma reagin (RPR), as well as HBV carriers;
14. History of alcohol abuse, drug abuse, or mental illness in the subject;
15. The subject participated in any other clinical study within 3 months before joining this clinical study;
16. Female subjects with any of the following conditions: a) Currently pregnant or breastfeeding; or b) Having a pregnancy plan during the trial period; or c) Being fertile but unable to take effective contraceptive measures;
17. Other circumstances that, in the opinion of the investigator, make 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
• 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.