Study on Natalizumab for Preventing Brain Inflammation in Patients with Recurrent or Resistant Large B-Cell or Mantle Cell Lymphoma Receiving CAR T-Cell Therapy

Sponsor: University of Michigan Rogel Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07892027

Provider View

This clinical trial is testing whether the drug natalizumab can prevent brain inflammation, known as ICANS, in patients with certain types of lymphoma who are receiving CAR T-cell therapy. ICANS is a common side effect of this treatment, and natalizumab may help reduce its severity.

Patient Parameters

Program Overview

This study is exploring the use of natalizumab to prevent a condition called ICANS, which is brain inflammation that can occur in patients with diffuse large B-cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) who are receiving CAR T-cell therapy. ICANS is a serious side effect that currently requires treatment with high-dose steroids, which can interfere with the effectiveness of CAR T-cell therapy. Natalizumab works by stopping immune cells from moving into the brain area, potentially reducing the risk of ICANS. The study aims to see if natalizumab is safe and effective in lowering the chances of severe ICANS in these patients.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must understand and agree to sign a consent form before any study-related activities.
  • Must be willing to follow the study schedule and requirements.
  • Must have a performance status score of 2 or less, indicating they are able to carry out light work.
  • Must be eligible for specific CAR T-cell therapies for relapsed or resistant large B-cell or mantle cell lymphoma.
  • Must agree to use effective birth control methods during the study and for a specified time after treatment, if of childbearing potential.

Exclusion Criteria

  • Have an uncontrolled infection despite treatment.
  • Have a history of or current infection with JC virus.
  • Have active hepatitis B or C, or HIV, unless under control.
  • Have high levels of bilirubin or liver enzymes unless due to specific conditions.
  • Have an active autoimmune disease needing immunosuppressive treatment.
  • Have active lymphoma in the central nervous system.
  • Have significant brain or nervous system conditions, such as seizures, recent stroke, or severe brain injury.
  • Be pregnant or breastfeeding.
  • Have a history of certain brain infections or conditions like PML.
  • Be currently using other treatments to prevent ICANS, except for seizure medications.
  • Have had a reaction to natalizumab or its ingredients.
  • Have any other serious health condition that could affect the study.

Locations

FACILITYZIPCITYSTATE
University of Michigan Rogel Cancer Center48109Ann ArborMichigan

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