University of Michigan Rogel Cancer Center
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.
Inclusion Criteria: * Patient must be ≥ 18 years of age at the time of signing informed consent (ICF) * Patient must understand and voluntarily sign the ICF prior to conduct of any study-related assessments or procedures * Patient must be willing to adhere to the study visit schedule and other protocol requirements * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Patient must be eligible per institutional criteria for therapy with commercial axicabtagene ciloleucel or brexucabtagene autoleucel for treatment of relapsed or refractory diffuse large B-cell lymphoma or mantle…
Given axicabtagene ciloleucel
Undergo collection of blood
Given brexucabtagene autoleucel
Undergo PET/CT
Given IV
Given IV
Given IV
Undergo PET/CT