New drug may help more patients get Life-Saving CAR-T therapy
NCT ID NCT06784726
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This study tests whether giving the drug odronextamab before CAR-T cell therapy can help control aggressive large B-cell lymphomas that have returned or not responded to prior treatment. About 27 adults will receive odronextamab to slow disease progression and increase the chance they can successfully undergo leukapheresis and receive CAR-T therapy. The goal is to improve access to this potentially curative treatment for more patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 27 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Apr 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed large B cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, DLBCL arising from indolent lymphoma, follicular lymphoma (FL) grade 3B * 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 ≥ 45 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: * Detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases. Patients with a history of secondary central nervous system (CNS) lymphoma may be eligible provided that there has been no evidence of CNS disease from lymphoma for at least 3 months at the time of screening * 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, unless all the following are met: disease responded to prior bispecific therapy (CR or PR per Lugano criteria) and did not experience disease progression within 12 months of the last dose of prior bispecific therapy, and the tumor must still express CD20 (CD20 examination per standard of care \[SOC\]) * 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. A short course of corticosteroid for lymphoma disease control during screening is allowed * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fred Hutch/University of Washington Cancer Consortium
RECRUITINGSeattle, Washington, 98109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a Multi-Drug combo outsmart resistant lymphoma?
- Could adjusting chemo doses boost CAR T-Cell success against tough lymphoma?
- Radiation boost may supercharge CAR T-Cell therapy against tough lymphoma
- New combo therapy aims to stop aggressive lymphoma relapse
- New combo approach aims to boost CAR-T success in tough lymphoma