Efficacy and Safety of CD19CD20-CAR.p40-T in B-cell Lymphoma
1. Study Title: A Study on the Efficacy and Safety of Autocrine p40 CD19/CD20 Dual-Targeting Chimeric Antigen Receptor T-Cells (CD19/CD20-CAR.p40-T) in Relapsed/Refractory B-Cell Lymphoma 2. Study Objectives: * Primary Objective: To evaluate the safety of CD19/CD20 dual-targeting CAR.p40-T cell therapy in patients with
| Condition(s) | Relapsed/Refractory B-cell Lymphoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | 1. Study Title: A Study on the Efficacy and Safety of Autocrine p40 CD19/CD20 Dual-Targeting Chimeric Antigen Receptor T-Cells (CD19/CD20-CAR.p40-T) in Relapsed/Refractory B-Cell Lymphoma 2. Study Objectives: * Primary Objective: To evaluate the safety of CD19/CD20 dual-targeting CAR.p40-T cell therapy in patients with relapsed/refractory B-cell lymphoma. * Secondary Objective: To evaluate the efficacy of CD19/CD20 dual-targeting CAR.p40-T cell therapy in patients with relapsed/refractory B-cell lymphoma. 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.p40-T cell infusion or CD19 CAR.p40-T cell infusion. The CAR-T cell infusion will be administered |
| Who can participate | Inclusion Criteria: 1. Aged between 15 and 75 years old, regardless of gender; 2. Diagnosed with relapsed/refractory B-cell lymphoma according to the 2020 World Health Organization (WHO) diagnostic criteria; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 4. Expected survival time of ≥ 3 months; 5. Confirmation of CD20 expression in tumor cells by flow cytometry/immunohistochemistry; 6. Patients tolerant to CD19 CAR-T cell therapy or those with low CD19 expression; 7. No severe heart, lung, liver, or kidney diseases; 8. Capable of understanding and willing to sign the informed consent form for this trial; 9. No contraindications to peripheral blood apheresis for the subject; 10. Having clearly measurable and evaluable lesions according to the Response Evaluati |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Shenzhen University General Hospital |
| Locations | Shenzhen, Other (Non U.s.), China |
| Start date | 2023-10-01 |
| NCT ID | NCT07097207 |
| Official listing | https://clinicaltrials.gov/study/NCT07097207 |