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RECRUITING
NCT05672173
PHASE2

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

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

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.

Official title: Phase 2 Study of the Combination of Lisocabtagene Maraleucel, Nivolumab, and Ibrutinib in Richter's Transformation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-06-02

Completion Date

2026-09-10

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

PROCEDURE

Biopsy

Undergo tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo blood specimen collection

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy and/or aspiration

PROCEDURE

Computed Tomography

Undergo PET/CT

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

DRUG

Ibrutinib

Given PO

BIOLOGICAL

Lisocabtagene Maraleucel

Given IV

BIOLOGICAL

Nivolumab

Given IV

PROCEDURE

Pheresis

Undergo apheresis

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Locations (2)

City of Hope Medical Center

Duarte, California, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States