drugset / Trial / NCT06996132

Bispecific Antibody-Based Salvage Therapy Followed by CAR-T ± ASCT in R/R Aggressive B-Cell Lymphoma

NCT06996132

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

EvaluationDrugModalityDoseRoute
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