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CAR T-cell Therapy

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

Phase 2

Waitlist Available

Led By Reem Karmali, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Patients must have a histo-pathologically confirmed diagnosis of an aggressive B-cell non-Hodgkin lymphoma or transformed indolent B-cell lymphoma that is recurrent or refractory to standard therapy and with intent to treat with standard of care CAR T-cell therapy

Must not have

Patients with evidence of active disease in the central nervous system (CNS)

Patients who are unable to swallow oral tablet/gel capsules

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial is studying 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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include immune system reactions leading to inflammation in various organs, infusion-related reactions from the therapy administration, possible digestive disturbances due to medication intake, and an increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to get out of my bed or chair and move around.

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My aggressive B-cell lymphoma is not responding to standard treatments and I am considered for CAR T-cell therapy.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active disease in my brain or spinal cord.

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I cannot swallow pills or capsules.

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

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I haven't taken strong medication that affects liver enzymes in the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in 6-month complete response rates

Secondary study objectives

Conversion rates of partial response (PR) to CR

Incidence of adverse events

Overall response rate (ORR)

+2 more

Other study objectives

CAR T cell polyfunctionality

Changes in immune cell subsets and cytokines

Disease-specific symptoms and/or treatment-related concerns

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zanubrutinib

FDA approved

0 / 7Eligibility criteria met