Zanubrutinib and Lisocabtagene Maraleucel for the Treatment of Richter's Syndrome

Summary

This phase II trial tests how well zanubrutinib and lisocabtagene maraleucel (liso-cel) work together in treating patients with Richter's syndrome that has come back (recurrent) or does not respond to treatment (refractory). Richter's syndrome occurs when chronic lymphocytic leukemia and/or small lymphocytic leukemia transforms into an aggressive lymphoma, which is a cancer of the lymph nodes. Zanubrutinib is a class of medication called a kinase inhibitor. These drugs work by preventing the action of abnormal proteins that tell cancer cells to multiply, which helps stop the spread of cancer. Liso-cel is a type of treatment known as chimeric antigen receptor (CAR) T cell therapy. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving zanubrutinib and liso-cell together may kill more cancer cells in patients with recurrent or refractory Richter's syndrome.

Conditions

• Recurrent Transformed Chronic Lymphocytic Leukemia
• Refractory Transformed Chronic Lymphocytic Leukemia
• Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma
• Recurrent Transformed B-Cell Non-Hodgkin Lymphoma
• Recurrent Transformed Non-Hodgkin Lymphoma
• Refractory Transformed Non-Hodgkin Lymphoma
• Refractory Transformed B-cell Non-Hodgkin Lymphoma
• Refractory Transformed

Interventions

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

DRUG

Zanubrutinib

Given PO

PROCEDURE

Lymph Node Biopsy

Undergo lymph node biopsy

DRUG

Fludarabine

Given IV

PROCEDURE

Leukapheresis

Given IV

BIOLOGICAL

Lisocabtagene Maraleucel

Given IV

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Bone Marrow Biopsy

Undergo BM biopsy

PROCEDURE

Computed Tomography

Undergo CT and/or PET/CT

DRUG

Cyclophosphamide

Given IV

Sponsors & Collaborators

• BeOne Medicines

  collaborator INDUSTRY

• Aseel Alsouqi

  lead OTHER

Principal Investigators

• Jennifer A Woyach, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-28

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations