CD19/CD20 CAR/TRuC-T for relapsed or refractory B‑cell lymphoma

Efficacy and Safety of CD19/CD20 CAR/TRuC-T in Relapsed/Refractory B-Cell Lymphoma

This trial will try a single infusion of CD19/CD20 CAR/TRuC-T cells after short lymphodepleting chemotherapy in adults with relapsed or refractory B‑cell lymphoma to see if it is safe and can shrink tumors.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shenzhen University General Hospital (Academic / other)
• Drugs / interventions: CAR-T, chemotherapy, Cyclophosphamide, Fludarabine
• Locations: 1 site (Shenzhen, Guangdong)
• Trial ID: NCT07508605 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–75 with histologically confirmed relapsed or refractory CD20‑positive B‑cell lymphoma, ECOG 0–2, adequate organ function, prior first- and second-line therapy, and eligibility for apheresis and lymphodepleting chemotherapy.

Not a fit: Patients with CD20‑negative disease, severe cardiac/pulmonary/hepatic/renal dysfunction, contraindications to apheresis or lymphodepletion, or very limited life expectancy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the dual-targeted CAR/TRuC-T approach could produce deeper or more durable remissions for patients whose B‑cell lymphoma has returned or not responded to prior treatments.

How similar studies have performed: CD19-targeted CAR-T therapies have produced remissions in relapsed B‑cell lymphoma, and early-phase dual-targeted approaches such as CD19/CD20 CARs have shown promising signals but remain experimental.

Eligibility criteria

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 this trial is running

Shenzhen, Guangdong

• Shenzhen University General Hospital — Shenzhen, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Lixin Li, Phd

Conditions Relapsed/Refractory B-cell Lymphoma