Odronextamab for Relapsed and Refractory Large B-cell Lymphomas Before CAR-T
NCT ID: NCT06784726
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
27 participants
INTERVENTIONAL
2025-09-04
2033-04-11
Brief Summary
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Detailed Description
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Patients receive odronextamab intravenously (IV) on days 1, 2, 8, 9, 15 and 16 of cycle 1 (dose step-up), and on days 1, 8 and 15 of cycles 2-4 and then once every other week of remaining cycles. Cycles repeat every 21 days for the first 4 cycles, then every other week for up to a total of 12 months (including the first 2 cycles). After 2 cycles, patients undergo leukapheresis followed by lymphodepletion and CAR-T infusion per standard of care. If there is a significant delay of leukapheresis, patients may receive up to 12 additional weeks of treatment. Patients who achieve CR after cycle 2 may opt out of leukapheresis and CAR-T cell infusion and may continue to receive odronextamab in the absence of disease progression or unacceptable toxicity. Patients undergo positron emission tomography (PET)/computed tomography (CT), collection of blood and oral or rectal swab samples and tissue biopsy throughout the study. Additionally, patients may undergo lumbar puncture and bone marrow aspiration and/or biopsy on study.
After completion of study treatment, patients are followed till 90 days or the initiation of the next lymphoma directed therapy for toxicity check, and total duration of follow-up is up to 5 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (odronextamab)
Patients receive odronextamab IV based on the following schedules:
* Step-up dosing during cycle 1: 0.2 mg on C1D1, 0.5 mg on C1D2, 2 mg on C1D8 and C1D9, respectively, and 10 mg on C1D15 and C1D16, respectively (0.7/4/20 regimen).
* Dosing during cycles 2-4: Odron will be given at 160 mg weekly.
* Once every other week at 320 mg of remaining cycles.
Please see the Detailed Description for additional information.
Odronextamab
Given IV
Biospecimen Collection
Undergo collection of blood and oral or rectal swab samples
Bone Marrow Aspiration
Undergo bone marrow aspiration
Bone Marrow Biopsy
Undergo bone marrow biopsy
Chimeric Antigen Receptor T-Cell Therapy
Undergo CAR-T cell therapy
Computed Tomography
Undergo PET/CT
Leukapheresis
Undergo leukapheresis
Lumbar Puncture
Undergo lumbar puncture
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
Biopsy
Undergo tissue biopsy
Interventions
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Odronextamab
Given IV
Biospecimen Collection
Undergo collection of blood and oral or rectal swab samples
Bone Marrow Aspiration
Undergo bone marrow aspiration
Bone Marrow Biopsy
Undergo bone marrow biopsy
Chimeric Antigen Receptor T-Cell Therapy
Undergo CAR-T cell therapy
Computed Tomography
Undergo PET/CT
Leukapheresis
Undergo leukapheresis
Lumbar Puncture
Undergo lumbar puncture
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
Biopsy
Undergo tissue biopsy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease, defined as at least one measurable lesion ≥ 15 mm on PET, CT, or magnetic resonance imaging (MRI) within one month of screening, according to the International Working Group consensus response evaluation criteria in lymphoma
* Prior frontline therapy for large B cell lymphoma must have failed the patient, and criteria must be met for receiving commercial axicabtagene ciloleucel (axi-cel), lisocabtagene maraleucel (liso-cel), or tisagenlecleucel (tisa-cel) per Food and Drug Administration (FDA) label
* Age ≥ 18 years
* Capable of understanding and providing a written informed consent
* Prior treatment with an anti-CD20 antibody therapy
* Eastern Cooperative Oncology Group performance status of 0-1; we allow enrollment of patients with a performance status of 2 if it is attributed to lymphoma per discretion of the treating physician or principal investigator (PI)
* Creatinine clearance ≥ 50 mL/min calculated by Cockcroft-Gault equation
* Total bilirubin ≤ 1.5 x the upper limit of normal (ULN), except in patients with Gilbert's syndrome
* Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x the ULN
* Adequate pulmonary function, defined as ≤ grade 1 dyspnea and oxygen saturation (SpO2) ≥ 92% on room air
* Adequate cardiac function, defined as left ventricular ejection fraction ≥ 50% and without evidence for pericardial effusion
* Platelet count ≥ 75 x 10\^9 /L
* Hemoglobin (Hg) level ≥ 9 g/dL
* Absolute neutrophil count (ANC) ≥ 1 x 10\^9 /L
* Patients with bone marrow involvement or splenic sequestration: Platelet count ≥ 25 x 10\^9 /L
* Patients with bone marrow involvement or splenic sequestration: Hg ≥ 7.0 g/dL
* Patients with bone marrow involvement or splenic sequestration: ANC ≥ 0.5 x 10\^9 /L
* Negative serum pregnancy test within 2 days of initiating odronextamab for women of childbearing potential (WOCBP), defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year
* Fertile male and WOCBP patients must be willing to use highly effective contraceptive methods from study recruitment to at least 6 months after the CAR T-cell infusion
* Patients must not provide egg or sperm donation until at least 6 months after the completion of the last dose of Odron
Exclusion Criteria
* History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement
* Standard anti-neoplastic chemotherapy (non-biologic) within 5-times the half-life or within 2 weeks, whichever is shorter, prior to first administration of study drug
* Standard radiotherapy within 2 weeks of first administration of study drug
* Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy
* Allogeneic stem cell transplantation
* Any CAR-T cell therapy
* Patients may not be receiving other investigational agents
* Treatment with rituximab, alemtuzumab, or other investigational or commercial biologic agent within 2 weeks prior to first administration of study drug
* Immunosuppressive therapy (other than biologic) within 2 weeks of first administration of study drug
* Treatment with an investigational non-biologic agent within 2 weeks of first administration of study drug
* History of allergic reactions attributed to compounds of similar chemical or biologic composition of study drug
* History of hypersensitivity to any compound in the tetracycline antibiotics group
* Concurrent active malignancy for which the patient is receiving systemic treatment, unless approved by PI
* Known active and uncontrolled bacterial, viral, fungal, mycobacterial, or other infection
* Evidence of significant concurrent disease or medical condition that could interfere with the conduct of the study, or put the patient at significant risk including, but not limited to, significant cardiovascular disease (e.g., New York Heart Association class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) and/or significant pulmonary disease (e.g., obstructive pulmonary disease and history of symptomatic bronchospasm)
* Ongoing systemic corticosteroid treatment, with the exception of corticosteroid use for other (non-tumor and non-immunosuppressive) indications up to a maximum of 10 mg/day of prednisone or equivalent
* Infection with human immunodeficiency virus (unless viral load is undetectable and CD4 count ≥ 400) or chronic infection with hepatitis B virus or hepatitis C virus. Patients with hepatitis B (hepatitis B surface antigen positive \[HepBsAg+\]) with controlled infection were permitted upon consultation with the physician managing the infection
* Known hypersensitivity to both allopurinol and rasburicase
* Pregnant or breast-feeding women
* Administration of live vaccination within 28 days of first administration of study drug
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Mengyang Di, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2024-10534
Identifier Type: REGISTRY
Identifier Source: secondary_id
FHIRB0020747
Identifier Type: OTHER
Identifier Source: secondary_id
RG1124641
Identifier Type: -
Identifier Source: org_study_id
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