Zanubrutinib + CAR T-Cell Therapy for Non-Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+2 other locations

Reem Karmali, MD, MS: Robert H. Lurie ...

Overseen byReem Karmali

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Northwestern University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults with certain aggressive B-cell non-Hodgkin's lymphoma or transformed indolent B-cell lymphoma that is resistant to standard treatments. Participants must have a life expectancy over 12 weeks, acceptable organ function, and no active infections or severe heart conditions. Pregnant women, nursing mothers, HIV patients, and those unable to swallow pills are excluded.

Inclusion Criteria

I agree to use effective birth control during and for 6 months after the study.

Patients must have a life expectancy of greater than 12 weeks

Ability to understand and the willingness to sign a written informed consent document

+11 more

Exclusion Criteria

I have active disease in my brain or spinal cord.

I cannot swallow pills or capsules.

I do not have stomach or intestine problems that affect medication absorption.

+6 more

Participant Groups

The trial studies the combination of zanubrutinib (a drug blocking enzymes for cell growth) with CAR T-cell therapy (patient's T cells engineered to target cancer cells). It aims to see if this combo is more effective in treating specific types of recurrent or unresponsive B-cell lymphomas.

1Treatment groups

Experimental Treatment

Group I: Treatment (zanubrutinib and CAR T-cell therapy)Experimental Treatment4 Interventions

LEAD- IN PHASE: Patients receive zanubrutinib PO BID for 7-14 days in the absence of disease progression or unacceptable toxicity. CAR T-CELL THERAPY: Patients receive standard of care CAR T-cell therapy IV at 4 weeks. MAINTENANCE PHASE: Patients receive zanubrutinib PO BID on days 1-28. Cycles repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity.

Chimeric Antigen Receptor T-Cell Therapy is already approved in European Union, United States, European Union, United States, European Union, United States, European Union, United States, European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Tisagenlecleucel for: