drugset / Trial / NCT06464185
A Prospective Clinical Study of CD3-CD20 Bisspecific Antibody Based Therapy Combined With CD19-CAR T Cells in the Treatment of Relapsed Refractory B-cell Non-Hodgkin Lymphoma
Phase 1/2
Active not recruiting
53 enrolled
Institute of Hematology & Blood Diseases Hospital, China
NaSingle-groupOpen-labelTreatment
Summary
The aim of this study was to analyze the safety and efficacy of CD3-CD20 bispecific antibody-based therapy in combination with CD19-CAR-T cells for the treatment of relapsed and refractory B-cell Non-Hodgkin's （B-NHL） lymphoma. The main questions it aims to answer： 1. The safety of CD3-CD20 bispecific antibody-based therapy in combination with CD19-CAR-T cells in B-NHL; 2. The effect of different doses of bispecific antibody maintenance therapy on CAR-T cell expansion.
Timeline
- Start
- 2024-04-30
- Primary completion
- 2026-03-30
- Completion
- 2027-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD19 CAR-T cells | Cell therapy | 4e+06 cells/kg | Intravenous |
| Subject | Glofitamab | Monoclonal antibody | 30 mg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |
| Background | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |