Study on Nemtabrutinib and Lisocabtagene Maraleucel for Treating Relapsed or Resistant Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Sponsor: Fred Hutchinson Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07194980

Provider View

This clinical trial is exploring a new treatment combination for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that has returned after treatment or hasn't responded to previous therapies. The study combines a drug called nemtabrutinib with a type of cell therapy known as CAR T-cell therapy to see if it can effectively treat these conditions.

Patient Parameters

Program Overview

The purpose of this study is to test if adding nemtabrutinib to a CAR T-cell therapy called lisocabtagene maraleucel can help treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or is not responding to treatment. Nemtabrutinib works by blocking certain enzymes that cancer cells need to grow. CAR T-cell therapy involves changing a patient's own immune cells in the lab to help them attack cancer cells. This study aims to find out if this combination can be an effective treatment for relapsed or resistant CLL/SLL.

Description

In this study, patients will take nemtabrutinib by mouth every day for 28 days in each cycle, except during a specific part of the treatment called lymphodepleting therapy. These cycles can continue for up to a year after receiving the CAR T-cell therapy, as long as the disease doesn't get worse and there are no serious side effects.

Patients will undergo a procedure called leukapheresis, where blood is taken from the body, white blood cells are separated out, and the rest of the blood is returned to the body. This happens 7 days after starting nemtabrutinib.

Patients will also receive standard lymphodepleting therapy, which includes two chemotherapy drugs, cyclophosphamide and fludarabine, given through a vein. This is done a few days before receiving the CAR T-cell therapy.

The CAR T-cell therapy, lisocabtagene maraleucel, is given through a vein 36-96 hours after the lymphodepleting therapy.

Throughout the study, patients will have various tests, including heart scans, PET/CT scans, bone marrow biopsies, lymph node biopsies, and blood tests to monitor their health and the treatment's effects.

After finishing the study treatment, patients will be followed for 5 years to monitor their long-term health and any effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • Have measurable disease, such as a lymph node larger than 1.5 cm or a high number of lymphocytes in the blood.
  • Be eligible for the CAR T-cell therapy lisocabtagene maraleucel as per FDA guidelines.
  • Be at least 18 years old.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Be able to swallow and retain oral medication.
  • If positive for hepatitis B, must have been on antiviral therapy for at least 4 weeks and have an undetectable viral load.
  • Have adequate blood cell counts and organ function as determined by specific medical tests.
  • Women of childbearing potential must agree to use effective contraception during the study and have a negative pregnancy test before starting treatment.

Exclusion Criteria

  • Have a diagnosis of Richter Transformation.
  • Have significant central nervous system involvement by the disease.
  • Have an active or uncontrolled infection.
  • Have active hepatitis B or C infection.
  • Have HIV with a detectable viral load or low CD4 count, unless on stable antiretroviral therapy.
  • Have gastrointestinal issues that affect drug absorption.
  • Have any condition or history that might interfere with the study or not be in the patient's best interest.
  • Have significant heart rhythm abnormalities.
  • Have an allergy to nemtabrutinib or its components.
  • Have a history of severe bleeding disorders.
  • Have a history of another cancer, unless successfully treated.
  • Be pregnant or planning to become pregnant during the study.
  • Need additional bridging therapy beyond nemtabrutinib.
  • Be taking certain medications that interact with the study drugs.
  • Have received a live vaccine recently.
  • Be enrolled in another clinical trial or have used an investigational device recently.
  • Have not recovered from major surgery or have ongoing complications.
  • Have psychiatric or substance abuse disorders that would interfere with the study.

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