CD19/CD20 CAR/TRuC-T 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 prospective Phase 1/2 interventional study will enroll 20 adults (ages 18–75) with histologically confirmed, CD20‑positive relapsed or refractory B‑cell lymphoma. Participants undergo lymphodepleting chemotherapy with fludarabine and cyclophosphamide before receiving a single intravenous infusion of CD19/CD20 CAR/TRuC-T cells at 0.5–2 × 10^6 CAR-T cells/kg. The primary endpoint is the incidence and severity of treatment-emergent adverse events within 30 days of infusion; secondary endpoints include objective response rate within 8 weeks and overall and progression-free survival at 6 months, along with measurement of in vivo CAR-T expansion and persistence. The protocol requires prior standard first- and second-line therapies and confirmation of CD20 expression on tumor tissue.

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, regardless of sex;
2. Histologically confirmed relapsed/refractory B-cell lymphoma according to the 2020 World Health Organization (WHO) classification;
3. ECOG performance status of 0-2;
4. Expected survival of at least 3 months;
5. CD20 expression on tumor cells confirmed by flow cytometry and/or immunohistochemistry;
6. Patients who are resistant/refractory to CD19 CAR-T cell therapy or have low CD19 expression;
7. No severe cardiac, pulmonary, hepatic, or renal disease;
8. Able to understand and willing to sign the informed consent form for this study;
9. No contraindications to peripheral blood mononuclear cell collection/apheresis;
10. At least one measurable and evaluable lesion according to RECIST 1.1;
11. Must have previously received standard first-line and second-line therapy;
12. No antibody-based therapy within 2 weeks prior to cell therapy. Exclusion Criteria

Subjects meeting any of the following criteria will be excluded:

1. History of allergy to any component of the cell product;
2. Abnormal complete blood count meeting any of the following: WBC ≤1 × 10⁹/L, ANC ≤0.5 × 10⁹/L, ALC ≤0.5 × 10⁹/L, or PLT ≤25 × 10⁹/L;
3. Laboratory abnormalities including, but not limited to, any of the following: total serum bilirubin ≥1.5 mg/dL; ALT or AST \>2.5 times the upper limit of normal; serum creatinine ≥2.0 mg/dL;
4. New York Heart Association (NYHA) Class III or IV heart failure, or left ventricular ejection fraction (LVEF) \<50% on echocardiography;
5. Abnormal pulmonary function, with oxygen saturation \<92% on room air;
6. History of myocardial infarction, cardiac angioplasty or stenting, 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 craniocerebral trauma, disturbance of consciousness, epilepsy, severe cerebral ischemia, or cerebral hemorrhagic disease;
9. Presence of autoimmune disease, immunodeficiency, or other conditions requiring immunosuppressive therapy;
10. Presence of 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 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 study;
16. Female subjects meeting any of the following conditions:

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

Where it's running

• Shenzhen University General Hospital
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: Lixin Li, Phd
• Email: wanglixin1991@sohu.com
• Phone: 0755-21839999

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.