Study on Nemtabrutinib and CAR T Therapy for Relapsed or Hard-to-Treat Mantle Cell Lymphoma

Sponsor: Vanderbilt-Ingram Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07673367

Provider View

This clinical trial is exploring a new treatment combining nemtabrutinib and CAR T-cell therapy to help patients with mantle cell lymphoma that has returned or not responded to previous treatments. The study aims to determine if this combination is safe and effective in reducing cancer.

Patient Parameters

Program Overview

This study is testing a new treatment approach for patients with mantle cell lymphoma that has either come back after treatment or not responded to previous therapies. The treatment combines nemtabrutinib, a drug that may stop cancer cell growth, with CAR T-cell therapy, which uses modified immune cells to attack cancer. Patients will receive chemotherapy before the CAR T-cell therapy to help prepare their bodies for the treatment. The study will evaluate if this combination is safe and effective in treating mantle cell lymphoma.

Description

The main goal of this study is to see how well nemtabrutinib works with CAR T-cell therapy (brexu-cel) in treating mantle cell lymphoma that has returned or is hard to treat. Researchers will also look at how the cancer responds to the treatment and how long patients survive after receiving it. They will monitor the safety of using nemtabrutinib with CAR T-cell therapy.

The study is divided into three phases:

  1. Pre-CAR T Phase (4-5 weeks): Patients will take nemtabrutinib daily for about a month before receiving CAR T-cell therapy. They will also receive chemotherapy to help prepare their bodies for the CAR T cells.

  2. CAR T Infusion Phase (4-5 weeks): Patients will receive the CAR T-cell therapy through an IV on a specific day.

  3. Post CAR T Phase (up to 24 months): Starting about a month after the CAR T-cell therapy, patients will continue taking nemtabrutinib daily in cycles that repeat every 28 days for up to two years, as long as the cancer does not progress and there are no severe side effects.

Throughout the study, patients will undergo various tests, including scans and blood tests, to monitor their health and the treatment's effects. After completing the study treatment, patients will have follow-up visits for up to five years.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of mantle cell lymphoma that has returned or not responded to treatment.
  • Be at least 18 years old and able to provide informed consent.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Be able to swallow oral medication.
  • Have controlled hepatitis B or C infections if applicable.
  • Have controlled HIV infection if applicable.
  • Have adequate organ function and specific blood cell counts.
  • Agree to use effective contraception during and after the study if capable of having children.

Exclusion Criteria

  • Have gastrointestinal issues that affect drug absorption.
  • Have a history of Richter transformation.
  • Have active central nervous system involvement with lymphoma.
  • Have an active infection requiring IV antibiotics.
  • Have had an AIDS-defining infection in the past year.
  • Have significant heart rhythm issues or other serious health conditions.
  • Have a known allergy to nemtabrutinib.
  • Have a history of severe bleeding disorders.
  • Have had another cancer unless treated and in remission for two years.
  • Be pregnant or breastfeeding.
  • Have received certain medications or treatments recently that could interfere with the study.
  • Have active autoimmune diseases requiring treatment in the past two years.
  • Have not recovered from major surgery.

Locations

FACILITYZIPCITYSTATE
Vanderbilt University/Ingram Cancer Center37203NashvilleTennessee

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