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

Recruiting now · Phase 1/Phase 2

Conditions studied: Relapsed/Refractory B-cell Lymphoma

In brief

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.

Key facts

Study ID

NCT07508605

Run by

Shenzhen University General Hospital

People needed

20

Starts

2025-01-01

Expected to finish

2027-12-30

Last updated by the study team

2026-04-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• No antibody-based therapy within 2 weeks prior to cell therapy. Exclusion Criteria
• 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;

Where it is running

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

Full record on ClinicalTrials.gov

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