Actively Recruiting
Odronextamab for the Treatment of Relapsed and Refractory Diffuse Large B-cell Lymphoma Before and After Chimeric Antigen Receptor T-cell Therapy
Led by Joseph Tuscano · Updated on 2025-09-29
34
Participants Needed
1
Research Sites
190 weeks
Total Duration
On this page
Sponsors
J
Joseph Tuscano
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests how well odronextamab works before and after standard of care (SOC) chimeric antigen receptor (CAR) T-cell therapy in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). CAR-T cell therapy is the SOC treatment most patients receive when other treatments have failed. CAR-T cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Odronextamab is a monoclonal antibody that is called bispecific, as it individually targets 2 cell proteins, CD20 and CD3. Proteins are part of each cell in the body, which work together like little machines for the cell to function. CD20 is a protein that is found on the surface of both normal B-cells and B-cells that make up certain cancers, like DLBCL. CD3 is a protein that is found on the surface of T cells. T-cells and normal B-cells are types of white blood cells in the body and are a part of the immune system that fights infections. Odronextamab is designed to help T-cells find and kill the B-cells including the cancer cells in DLBCL. Giving odronextamab before and after CAR T-cell therapy may improve response in patients with relapsed or refractory DLBCL.
CONDITIONS
Official Title
Odronextamab for the Treatment of Relapsed and Refractory Diffuse Large B-cell Lymphoma Before and After Chimeric Antigen Receptor T-cell Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- Histologically or cytologically confirmed relapsed or refractory diffuse large B-cell lymphoma or transformed follicular lymphoma
- Failed at least two prior therapies
- Life expectancy of at least 3 months
- Eligible for FDA-approved CAR T-cell therapy as per institutional guidelines
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky score ≥ 50%)
- Leukocyte count ≥ 2,500/µL
- Absolute neutrophil count ≥ 1,000/µL or > 500/µL for patients with bone marrow involvement
- Platelet count ≥ 50,000/µL or ≥ 25,000/µL for patients with bone marrow involvement
- Total bilirubin ≤ 1.5 times the institutional upper limit of normal (ULN); patients with Gilbert syndrome allowed if bilirubin ≤ 3 times ULN
- AST and ALT ≤ 3 times ULN (≤ 5 times ULN for patients with liver involvement)
- Creatinine clearance ≥ 30 mL/min/1.73 m² by Cockcroft-Gault formula
- Hemoglobin ≥ 8 g/dL (≥ 7 g/dL with bone marrow involvement)
- Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN for liver or bone metastases involvement)
- INR and aPTT ≤ 1.5 times ULN (patients on therapeutic anticoagulation must be on a stable dose)
- Cardiac ejection fraction > 50% by echocardiogram or MUGA scan
- Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 50 mL/min
- For HIV-infected patients: no history of AIDS-defining conditions other than lymphoma, undetectable viral load within 6 months, CD4+ T-cell count ≥ 250/mm³, no documented infections due to HIV during prior lymphoma therapy, adherence to antiretroviral therapy (ART), and no overlapping toxic antiretroviral drugs
- Patients with hepatitis B or C on suppressive therapy with negative viral load and no liver damage
- People of child-bearing potential and their partners must agree to use effective contraception during and for 6 months after the study
- Willing and able to provide informed consent
You will not qualify if you...
- Any condition or laboratory abnormality that poses unacceptable risk or confounds study data interpretation
- Known involvement of primary central nervous system (CNS) lymphoma or uncontrolled CNS non-Hodgkin lymphoma
- History or presence within 12 months of CNS pathology such as epilepsy, seizures, stroke, severe brain injury, psychosis, or inflammatory brain lesions
- Another active cancer within the past 5 years except certain treated skin cancers, in situ cervical carcinoma, or tumors effectively treated with curative intent
- Active infection requiring ongoing treatment or causing severe disease risk
- Active COVID-19 infection
- Uncontrolled infection with HIV, hepatitis B, or hepatitis C
- Detectable cytomegalovirus (CMV) levels at screening without successful antiviral treatment
- Continuous systemic corticosteroid treatment exceeding 10 mg prednisone or equivalent within 72 hours before treatment
- Major surgery within 4 weeks before starting study treatment
- Radiotherapy within 14 days before first study treatment
- Prior organ transplantation
- Live vaccination within 28 days before first dose
- Use of other experimental drugs within 28 days before study treatment
- Concurrent use of other anti-cancer therapies except some hormonal therapies
- Uncontrolled systemic fungal, bacterial, or viral infections
- Pregnancy or breastfeeding
- Known allergies or hypersensitivity to allopurinol, rasburicase, or similar compounds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
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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