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New treatment option for Recurrent Diffuse Large B-Cell Lymphoma
Official title Odronextamab for Relapsed and Refractory Large B-cell Lymphomas Before CAR-T
ClinicalTrials.gov ID: NCT06784726
What this study is testing
What is Odronextamab?
Odronextamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent diffuse large b-cell lymphoma.
Also referred to as REGN1979, Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody REGN1979.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial tests the effectiveness of odronextamab given before chimeric antigen receptor T (CAR-T) cell therapy (bridging therapy) in patients with large B-cell lymphomas that have come back after a period of improvement (relapsed) or that have not responded to previous treatment (refractory). Odronextamab is a bispecific antibody that can bind to two different antigens at the same time.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed large B cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large...
- Measurable disease, defined as at least one measurable lesion ≥ 15 mm on PET, CT, or magnetic resonance imaging (MRI) within one month of screening...
- Prior frontline therapy for large B cell lymphoma must have failed the patient, and criteria must be met for receiving commercial axicabtagene...
- Age ≥ 18 years
- Capable of understanding and providing a written informed consent
You likely can't join if
- Detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases...
- History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous...
- Standard anti-neoplastic chemotherapy (non-biologic) within 5-times the half-life or within 2 weeks, whichever is shorter, prior to first...
- 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...
- Allogeneic stem cell transplantation
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
What rules you out
- 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)...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.