drugset / Trial / NCT05672173

Lisocabtagene Maraleucel, Nivolumab and Ibrutinib for the Treatment of Richter's Transformation

NCT05672173

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial tests how well adding lisocabtagene maraleucel (liso-cel) to nivolumab and ibrutinib works in treating patients with Richter's transformation. Liso-cel is in a class of medications called autologous cellular immunotherapy, a type of medication prepared by using cells from patient's own blood. It works by causing the body's immune system (a group of cells, tissues, and organs that protects the body from attack by bacteria, viruses, cancer cells and other substances that cause disease) to fight the cancer cells. Nivolumab is in a class of medications called monoclonal antibodies. It works by helping the immune system to slow or stop the grown of cancer. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. Giving ibrutinib and nivolumab with Liso-cel may kill more cancer cells in patients with Richter's transformation.

Timeline

Start
2023-06-02
Primary completion
2026-09-10
Completion
2026-09-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibrutinib Small molecule Oral
Subject Lisocabtagene Maraleucel Cell therapy Intravenous
Subject Nivolumab Monoclonal antibody Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Background Fludarabine Small molecule Intravenous