Efficacy and Safety of CD19/CD20 CAR/TRuC-T in Relapsed/Refractory B-Cell Lymphoma
Shenzhen University General Hospital
20 participants
Jan 1, 2025
INTERVENTIONAL
Conditions
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 Criteria12
- Subjects must meet all of the following criteria to be enrolled:
- Aged 18 to 75 years, regardless of sex;
- Histologically confirmed relapsed/refractory B-cell lymphoma according to the 2020 World Health Organization (WHO) classification;
- ECOG performance status of 0-2;
- Expected survival of at least 3 months;
- CD20 expression on tumor cells confirmed by flow cytometry and/or immunohistochemistry;
- Patients who are resistant/refractory to CD19 CAR-T cell therapy or have low CD19 expression;
- No severe cardiac, pulmonary, hepatic, or renal disease;
- Able to understand and willing to sign the informed consent form for this study;
- No contraindications to peripheral blood mononuclear cell collection/apheresis;
- At least one measurable and evaluable lesion according to RECIST 1.1;
- Must have previously received standard first-line and second-line therapy;
Exclusion Criteria21
- Subjects meeting any of the following criteria will be excluded:
- History of allergy to any component of the cell product;
- 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;
- 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;
- New York Heart Association (NYHA) Class III or IV heart failure, or left ventricular ejection fraction (LVEF) <50% on echocardiography;
- Abnormal pulmonary function, with oxygen saturation <92% on room air;
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant severe cardiac disease within 12 months prior to enrollment;
- Grade 3 hypertension with poor blood pressure control despite medication;
- History of craniocerebral trauma, disturbance of consciousness, epilepsy, severe cerebral ischemia, or cerebral hemorrhagic disease;
- Presence of autoimmune disease, immunodeficiency, or other conditions requiring immunosuppressive therapy;
- Presence of uncontrolled active infection;
- Prior treatment with any CAR-T cell product or other genetically modified T-cell therapy;
- Receipt of a live vaccine within 4 weeks prior to enrollment;
- Positive for HIV, HBV, HCV, or TPPA/RPR, or HBV carrier status;
- History of alcohol abuse, drug abuse, or psychiatric illness;
- Participation in any other clinical study within 3 months prior to enrollment in this study;
- Female subjects meeting any of the following conditions:
- currently pregnant or breastfeeding;
- planning to become pregnant during the study period; or
- of childbearing potential and unwilling or unable to use effective contraception;
- Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07508605