OncoMatch/Clinical Trials/NCT07892027
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
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
Is NCT07892027 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments for recurrent diffuse large b-cell lymphoma.
Treatment: Axicabtagene Ciloleucel · Brexucabtagene Autoleucel · Cyclophosphamide · Fludarabine · Natalizumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: CAR-T cell therapy (axicabtagene ciloleucel, brexucabtagene autoleucel) — relapsed or refractory diffuse large B-cell lymphoma or mantle cell lymphoma
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 cell lymphoma
Cannot have received: natalizumab (natalizumab)
History of prior exposure to natalizumab due to risk of neutralizing antibody formation
Lab requirements
Liver function
Bilirubin: ≥ 2.0 x upper limit of normal (ULN), unless attributed to Gilbert's Syndrome or to the patient's primary malignancy; AST: ≥ 5 x ULN, ALT: ≥ 5 x ULN
Bilirubin: ≥ 2.0 x upper limit of normal (ULN), unless attributed to Gilbert's Syndrome or to the patient's primary malignancy; AST: ≥ 5 x ULN, alanine aminotransferase (ALT): ≥ 5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Michigan Rogel Cancer Center · Ann Arbor, Michigan
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07892027 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior natalizumab disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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