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

Summary

1. Study Title: A Study on the Efficacy and safety of CD19/CD20 CAR/TRuC-T in Relapsed/Refractory B-Cell Lymphoma 2. Study Objectives: Primary Objective: To evaluate the safety of CD19/CD20 CAR/TRuC-T cell therapy in patients with relapsed/refractory B-cell lymphoma. Secondary Objective: To evaluate the efficacy of CD19/CD20 CAR/TRuC-T cell therapy in patients with relapsed/refractory B-cell lymphoma. Exploratory Objective: To assess in vivo expansion and persistence of infused CD19/CD20 CAR/TRuC-T cells. 3. Participant Intervention: Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19/CD20 CAR/TRuC-T cell infusion. The CAR/TRuC-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.

Eligibility

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.

Conditions2

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