A Phase 2 interventional study of Axicabtagene Ciloleucel and Biospecimen Collection in Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Mantle Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, sponsored by University of Michigan Rogel Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by University of Michigan Rogel Cancer Center · Phase 2, Interventional, and Supportive care
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.
1,432 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 359 are open to participants now.
This study's planned enrollment of 26 is below the median of 47 across 1,214 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →University of Michigan Rogel Cancer Center is the lead sponsor of 322 studies on the registry; 47 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 31 (67%) have results posted.
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Exclusion Criteria:
Uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate antibiotics or treatment
Active clinically relevant central nervous system disease including but not limited to:
Patients receive SOC conditioning therapy consisting of fludarabine IV and cyclophosphamide IV on days -4 and -3. Patients then receive natalizumab IV over 1 hour on day -1, followed by SOC CAR T-cell therapy with axicabtagene ciloleucel or brexucabtagene autoleucel on day 0. Patients also undergo PET/CT and blood sample collection throughout the study.
Biological: Axicabtagene Ciloleucel · Procedure: Biospecimen Collection · Biological: Brexucabtagene Autoleucel · Procedure: Computed Tomography · Drug: Cyclophosphamide · Drug: Fludarabine · Biological: Natalizumab · Procedure: Positron Emission Tomography
Given axicabtagene ciloleucel
Also known as: Axi-cel, Axicel, KTE C19, KTE-C19, KTE-C19 CAR, KTEC19, Yescarta
Undergo collection of blood
Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Given brexucabtagene autoleucel
Also known as: Anti-CD19 Autologous CAR-CD28 T-cells KTE-X19, Brexu-cel, KTE X19, KTE-X19, KTEX19, Tecartus
Undergo PET/CT
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography
Given IV
Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518, B-518, B518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Frindovyx, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR 138719, WR- 138719, WR-138719, WR138719
Given IV
Also known as: Fluradosa
Given IV
Also known as: AN100226, Antegren, Anti-alph4 Integrin Monoclonal Antibody AN100226, Anti-VLA4, Tysabri
Undergo PET/CT
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Occurrence of chimeric antigen receptor therapy (CAR-T)-associated neurotoxicity (immune effector cell associated neurotoxicity syndrome [ICANS])
Any grade per American Society for Transplantation and Cellular Therapy Cytokine Release Syndrome (ASTCT) criteria. Will be considered binary and the rate will be defined as number of patients without ICANS of any grade divided by the number of evaluable patients. These rates will be reported along with the 95% exact binomial confidence interval.
Time frame: Up to CAR-T day +28
Occurrence of severe CAR-T-associated neurotoxicity (ICANS of grade 3 or greater)
Defined by ASTCT consensus criteria. Will be considered binary and the rate will be defined as number of patients with severe ICANS divided by the number of evaluable patients. These rates will be reported along with the 95% exact binomial confidence interval.
Time frame: Up to CAR-T day +28
Occurrence of severe cytokine release syndrome (cytokine release syndrome [CRS] of grade 3 or greater)
Defined by ASTCT consensus criteria. Will be considered binary, and the rate will be defined as number of patients with severe CRS divided by the number of evaluable patients. These rates will be reported along with the 95% exact binomial confidence interval.
Time frame: Up to CAR-T day +28
Occurrence of adverse events related to natalizumab
Treatment emergent adverse events will be tabulated, and the rate will be defined as number of patients with treatment emergent adverse events divided by the number of evaluable patients. These rates will be reported along with the 95% exact binomial confidence interval.
Time frame: Up to CAR-T day +28
Occurrence of complete response or partial response
Assessed per Lugano classification on day +60 positron emission tomography/computed tomography. Will be defined as number of patients with treatment emergent adverse events divided by the number of evaluable patients. These rates will be reported along with the 95% exact binomial confidence interval.
Time frame: At CAR-T day +60
Occurrence of serious adverse events related to natalizumab
Treatment emergent serious adverse events will be tabulated, and the rate will be defined as number of patients with treatment emergent adverse events divided by the number of evaluable patients. These rates will be reported along with the 95% exact binomial confidence interval.
Time frame: Up to CAR-T day +28
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Natalizumab
Lymphoma, Large B-Cell, Diffuse →
University of Michigan Rogel Cancer Center →