Actively Recruiting
Odronextamab for Relapsed and Refractory Large B-cell Lymphomas Before CAR-T
Led by University of Washington · Updated on 2026-05-06
27
Participants Needed
1
Research Sites
396 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. Odronextamab binds to CD3, a T-cell surface antigen, and CD20 (a tumor-associated antigen that is expressed on B-cells during most stages of B-cell development and is often overexpressed in B-cell cancers) and may interfere with the ability of cancer cells to grow and spread. Bridging therapy has been used to maintain disease control and to increase the chance of successful receipt of CAR-T cell therapy. However, bridging therapy is typically given after leukapheresis, which does not help prevent disease progression between the decision for CAR-T cell therapy and leukapheresis. Giving odronextamab as bridging therapy before leukapheresis may delay disease progression to allow leukapheresis and increase the likelihood of successful CAR-T cell therapy in patients with relapsed or refractory large B-cell lymphomas.
CONDITIONS
Official Title
Odronextamab for Relapsed and Refractory Large B-cell Lymphomas Before CAR-T
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed large B-cell lymphoma including diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, transformed indolent lymphoma, or follicular lymphoma grade 3B
- Measurable disease with at least one lesion 15 mm or larger on PET, CT, or MRI within one month of screening
- Prior frontline therapy for large B-cell lymphoma must have failed
- Eligible for commercial CAR-T therapies axicabtagene ciloleucel, lisocabtagene maraleucel, or tisagenlecleucel per FDA label
- Age 18 years or older
- Able to understand and provide written informed consent
- Prior treatment with anti-CD20 antibody therapy
- Eastern Cooperative Oncology Group performance status 0-1; performance status 2 allowed if due to lymphoma as determined by physician or principal investigator
- Creatinine clearance 45 mL/min or higher by Cockcroft-Gault equation
- Total bilirubin 1.5 times upper limit of normal or less, except patients with Gilbert's syndrome
- Aspartate aminotransferase and alanine aminotransferase 2.5 times upper limit of normal or less
- Adequate lung function defined as grade 1 or less dyspnea and oxygen saturation 92% or higher on room air
- Adequate heart function with left ventricular ejection fraction 50% or higher and no pericardial effusion
- Platelet count 75 x 10^9/L or higher
- Hemoglobin level 9 g/dL or higher
- Absolute neutrophil count 1 x 10^9/L or higher
- For patients with bone marrow involvement or splenic sequestration: platelet count 25 x 10^9/L or higher, hemoglobin 7.0 g/dL or higher, and absolute neutrophil count 0.5 x 10^9/L or higher
- Negative serum pregnancy test within 2 days before starting odronextamab for women of childbearing potential
- Fertile males and women of childbearing potential must use effective contraception from study start until 6 months after CAR-T infusion
- No egg or sperm donation until 6 months after last dose of odronextamab
You will not qualify if you...
- Presence of malignant cells in cerebrospinal fluid or brain metastases, or history of these unless no CNS lymphoma evidence for at least 3 months before screening
- History of seizure disorder, cerebrovascular events, dementia, cerebellar disease, or autoimmune disease involving the CNS
- Recent chemotherapy within 5 times its half-life or within 2 weeks before study drug start
- Radiotherapy within 2 weeks before study drug start
- Prior treatment with anti-CD20 x anti-CD3 bispecific therapy unless disease responded and no progression for 12 months, and tumor still expresses CD20
- Previous allogeneic stem cell transplant
- Prior CAR-T cell therapy
- Concurrent participation in other investigational drug studies
- Treatment with rituximab, alemtuzumab, or other biologics within 2 weeks before study drug start
- Use of immunosuppressive therapy other than biologics within 2 weeks before study drug start
- Treatment with investigational non-biologic agents within 2 weeks before study drug start
- History of allergic reactions to similar compounds or tetracycline antibiotics
- Active malignancy requiring systemic treatment unless approved by investigator
- Active uncontrolled infections
- Significant other medical conditions including severe heart or lung disease
- Ongoing systemic corticosteroid treatment above 10 mg/day prednisone equivalent, except short course for lymphoma control during screening
- HIV infection unless undetectable viral load and CD4 count 400 or higher
- Chronic hepatitis B or C infection unless controlled
- Known hypersensitivity to both allopurinol and rasburicase
- Pregnant or breastfeeding women
- Live vaccination within 28 days before first study drug dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
M
Mengyang Di, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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