Efficacy and Safety of CD19/CD20 CAR/TRuC-T in Relapsed/Refractory B-Cell Lymphoma
Eligible age
18–75 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Shenzhen University General Hospital
You may qualify if…
- ✓ 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;
Source: ClinicalTrials.gov · NCT07508605 · last updated 2026-04-02