Zanubrutinib and CAR T-cell Therapy for the Treatment of Recurrent or Refractory Aggressive B-cell Non-Hodgkin's Lymphoma or Transformed Indolent B-cell Lymphoma

Summary

This phase II trial studies the effect of zanubrutinib and CAR T-cell therapy in treating patients with aggressive B-cell non-Hodgkin's lymphoma or transformed indolent B-cell lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize CAR, a protein on the surface of cancer cells. These CAR-specific T cells may help the body's immune system identify and kill cancer cells. Giving zanubrutinib together with CAR T-cell therapy may kill more cancer cells.

Conditions

• Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation
• EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
• High Grade B-Cell Lymphoma, Not Otherwise Specified
• Large B-Cell Lymphoma With IRF4 Rearrangement
• Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type
• Recurrent Aggressive B-Cell Non-Hodgkin Lymphoma
• Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
• Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
• Recurrent Intravascular Large B-Cell Lymphoma
• Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma
• Recurrent T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
• Recurrent Transformed B-Cell Non-Hodgkin Lymphoma
• Refractory Aggressive B-Cell Non-Hodgkin Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
• Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
• Refractory Intravascular Large B-Cell Lymphoma
• Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma
• Refractory T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
• Refractory Transformed B-Cell Non-Hodgkin Lymphoma

Interventions

BIOLOGICAL

Chimeric Antigen Receptor T-Cell Therapy

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Zanubrutinib

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Northwestern University

  lead OTHER

Principal Investigators

• Reem Karmali, MD · Northwestern University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-21

Primary Completion

2026-10-09

Completion

2029-10-09

FDA Drug

Yes

Countries

• United States

Study Locations