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Natalizumab for the Prevention of ICANS in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma Receiving CAR T-Cell Therapy
Sponsor: University of Michigan Rogel Cancer Center
Summary
This phase II studies how well natalizumab works in preventing immune effector cell associated neurologic syndrome (ICANS) in patients with diffuse large B-cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) that has come back after a period of improvement (recurrent) or that does not respond to treatment (refractory) receiving chimeric antigen receptor (CAR) T-cell therapy. A major complication of CAR T-cell therapy is ICANS. ICANS is inflammation of the brain or nerves. ICANS currently requires high-dose corticosteroid treatment which can inhibit CAR T-cell response. Natalizumab prevents immune cells from traveling from the blood to the fluid around the brain, which is a process thought to play a major role in CAR T-cell related brain injury. Natalizumab may be safe and effective in decreasing the frequency of severe ICANS in patients with DLBCL or MCL receiving CAR T-cell therapy.
Official title: Phase II Trial of Natalizumab for Prevention of Immune Effector Cell Associated Neurologic Syndrome (ICANS) in Patients Treated With Chimeric Antigen Receptor T-Cell Therapy for B-Cell Hematologic Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
26
Start Date
2026-11-01
Completion Date
2028-05-01
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
Axicabtagene Ciloleucel
Given axicabtagene ciloleucel
Biospecimen Collection
Undergo collection of blood
Brexucabtagene Autoleucel
Given brexucabtagene autoleucel
Computed Tomography
Undergo PET/CT
Cyclophosphamide
Given IV
Fludarabine
Given IV
Natalizumab
Given IV
Positron Emission Tomography
Undergo PET/CT
Locations (1)
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States