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RECRUITING
NCT07892027
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Axicabtagene Ciloleucel

Given axicabtagene ciloleucel

PROCEDURE

Biospecimen Collection

Undergo collection of blood

BIOLOGICAL

Brexucabtagene Autoleucel

Given brexucabtagene autoleucel

PROCEDURE

Computed Tomography

Undergo PET/CT

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

BIOLOGICAL

Natalizumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Locations (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States