drugset / Trial / NCT06996132
Bispecific Antibody-Based Salvage Therapy Followed by CAR-T ± ASCT in R/R Aggressive B-Cell Lymphoma
NaSingle-groupOpen-labelTreatment
Summary
This study consists of two sequential treatment phases. In the first phase, patients with r/r aggressive B-NHL receive two cycles of glofitamab ± investigator-selected agents. In the second phase, patients eligible for CAR-T monotherapy undergo FC lymphodepletion followed by CAR-T infusion (2-4×10⁶/kg), while those eligible for CAR-T+ASCT receive conditioning chemotherapy with PBSC reinfusion on day 0 and CAR-T administration (2-4×10⁶/kg) on day +3 (±1). Patients demonstrating Deauville 4-5 or ctDNA positivity at day 28 post-CAR-T infusion subsequently receive four cycles of glofitamab consolidation therapy.
Timeline
- Start
- 2025-05-09
- Primary completion
- 2027-05-30
- Completion
- 2027-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Chimeric Antigen Receptor T Cells (CAR-T) | Cell therapy | 2e+06 cells/kg | — |
| Subject | Chimeric Antigen Receptor T Cells (CAR-T) | Cell therapy | 4e+06 cells/kg | — |
| Subject | Glofitamab | Monoclonal antibody | — | — |