Odronextamab for Relapsed/Refractory DLBCL Before and After CAR T-Cell Therapy
This study is testing a treatment called odronextamab, given before and after standard CAR T-cell therapy, for people with diffuse large B-cell lymphoma (DLBCL) that has come back or not responded to previous treatments. CAR T-cell therapy is a treatment where your own immune cells are specially trained to fight cancer. Researchers want to see how well odronextamab works to shrink the cancer (complete response rate). You might be able to join if you are 18 or older, have relapsed or refractory DLBCL (including transformed follicular lymphoma), and have tried at least two other treatments. The study plans to enroll 34 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 34 participants.
- What's involved
- You would receive odronextamab intravenously (IV) on a schedule that changes over time, potentially for up to two years. You would also undergo echocardiograms or MUGA scans, blood tests, and PET/CT or CT scans.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures complete response rate from the first dose through the completion of 5 cycles of odronextamab and CAR T-cell infusion.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06854159
Odronextamab for the Treatment of Relapsed and Refractory Diffuse Large B-cell Lymphoma Before and After Chimeric Antigen Receptor T-cell Therapy
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of California, DavisInvestigator-initiated
~34 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:Chimeric Antigen Receptor T-Cell TherapyOdronextamab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete response rate (CRR)
Measured over From first dose through completion of 5 cycles (cycle length = 21 days for cycles 1-4 and 14 days for cycle 5) of odronextamab and chimeric antigen receptor (CAR) T cell infusion
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Joseph M Tuscano, MD · PRINCIPAL_INVESTIGATOR · University of California, Davis
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Aged ≥ 18 at the time of consent
Patients must have histologically or cytologically confirmed relapsed/ refractory (R/R) diffuse large B-cell lymphoma (DLBCL); transformed follicular lymphoma patients are eligible
Patients must have failed at least 2 prior therapies
Life expectancy ≥ 3 months
Candidate for any Food and Drug Administration (FDA)-approved chimeric antigen receptor (CAR) T cell therapy as per institutional guidelines
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%)
Leukocytes ≥ 2,500/µL
Absolute neutrophil count ≥ 1,000/µL or \> 500/µL for patients with bone marrow involvement
A participant may not have received granulocyte colony stimulating factor within 2 days prior to first dose of odronextamab in order to meet the absolute neutrophil count (ANC) eligibility criterion
Platelets ≥ 50,000/µL or ≥ 25,000/µL for patients with bone marrow involvement
A patient may not have received platelet transfusion therapy within 2 days prior to first dose of odronextamab in order to meet the platelet eligibility criterion
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
NOTE: patients with known Gilbert disease who have serum bilirubin level ≤ 3 x institutional ULN may be enrolled. Patients with known Gilbert syndrome will be excluded if the total bilirubin value is \> 4 x ULN
Irrespective of the presence of lymphoma infiltration of the liver, a participant with an aspartate aminotransferase (AST) \> 3 x ULN and/or alanine aminotransferase (ALT) \> 3 x ULN concurrent with a total bilirubin \> 1.5 x ULN will be excluded
AST(serum glutamic oxaloacetic transaminase \[SGOT\])/ALT(serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN (AST and/or ALT ≤ 5 x ULN for patients with liver involvement)
Irrespective of the presence of lymphoma infiltration of the liver, a participant with an AST \> 3 x ULN and/or ALT \> 3 x ULN concurrent with a total bilirubin \> 1.5 x ULN will be excluded
Creatinine clearance ≥ 30 mL/min/1.73 m\^2 by Cockcroft-Gault
Hemoglobin ≥ 8 g/dL or ≥ 7 g/dL for patients with bone marrow involvement
NOTE: Growth factor or transfusion support is allowed as per treating physician's discretion
Alkaline phosphatase 2.5 x ULN (≤ 5 x ULN for patients with documented liver involvement or bone metastases)
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
NOTE: This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose
Cardiac ejection fraction \> 50% by echocardiogram or multigated acquisition (MUGA) scan
Serum creatinine ≤ 1.5 x ULN, or calculated creatinine clearance by Cockcroft Gault formula ≥ 50 mL/min
For participants infected with HIV:
No history of AIDS-defining conditions other than lymphoma or history of CD4+ T-cells below 200/mm\^3 prior to beginning combination antiretroviral therapy (ART)
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
At time of study entry CD4+ T-cells must have recovered from prior lymphoma therapy to ≥ 250/mm\^3
At the time of study entry, the HIV viral load must be undetectable by standard laboratory assay
During prior lymphoma therapy, patients must not have experienced documented infections attributed to the HIV+ status
No history of non-adherence to ART and willing to adhere to ART while on study
Antiretroviral drugs with overlapping or similar toxicity profiles as study agents not allowed
People with hepatitis B or C on suppressive therapy with a negative viral load and no evidence of hepatic damage are eligible
People of child-bearing potential and reproductive partners must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months (180 days) after the last dose of study agent. Egg and sperm donation is prohibited during the study and for 6 months after the last dose of study agent
Willing and able to provide informed consent
Exclusion
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she/they were to participate in the study or confounds the ability to interpret data from the study as determined by the study principal investigator (PI) or enrolling physician
Known involvement by primary central nervous system (CNS) lymphoma or known uncontrolled involvement by non-primary CNS non-Hodgkin lymphoma (NHL) at the time of study entry
Known history (within last 12 months) of or current relevant CNS pathology, such as:
Epilepsy, seizure, paresis, aphasia, apoplexy, severe brain injury, cerebellar disease, organic brain syndrome, psychosis, cerebrovascular stroke or
Evidence for presence of inflammatory lesions and/or vasculitis on cerebral magnetic resonance imaging (MRI)
Another active malignancy (aside from B-cell NHL) in the past 5 years, with the following exceptions: non-melanoma skin cancer that has undergone potentially curative therapy, in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent as per treating investigator
Evidence of any active infection (bacterial, viral, fungal, mycobacterial, parasitic, or other) at study enrollment or within 2 weeks of study enrollment, if requiring ongoing treatment and/or has the potential to cause disseminated disease or severe infection upon immunosuppression. There should be evidence that the infection has cleared or is well controlled by start of study therapy
Active COVID-19 infection
Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
Participants with HIV who have controlled infection (undetectable viral load and CD4 count above 350 cells/µL either spontaneously or on a stable antiviral regimen) are permitted.
Participants who are hepatitis B surface antigen positive or who are hepatitis B core antibody positive should undergo evaluation by a specialist and be considered to have controlled infection (serum hepatitis B virus deoxyribonucleic acid \[DNA\] polymerase chain reaction \[PCR\] that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) before they are permitted onto study
Participants who are HCV antibody positive who have controlled infection (undetectable HCV ribonucleic acid \[RNA\] by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted
Cytomegalovirus (CMV) infection as noted by detectable levels on peripheral blood polymerase chain reaction (PCR) assay. Patients who show detectable levels of CMV at screening will need to be treated with appropriate antiviral therapy and demonstrate at least 2 undetectable levels of CMV by PCR assay (at least 7 days apart) before being re-considered for eligibility
Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone/prednisolone or anti-inflammatory equivalent within 72 hours of start of assigned treatment
Recent major surgery (within 4 weeks prior to the start of study treatment)
Standard radiotherapy within 14 days of first administration of study treatment
Prior organ transplantation
Administration of live vaccination within 28 days of study first dose
Use of any other experimental drug or therapy within 28 days (or 5 half-lives of the drug, whichever is shorter) of initiating study treatment
Concurrent use of other anti-cancer treatments except for certain therapeutics (e.g., maintenance hormonal-based therapy) per the treating physician's discretion
Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment)
Pregnancy or lactation
Known allergic reactions or hypersensitivity to allopurinol, rasburicase, or compounds of similar chemical or biological components
What this trial measures
- Complete response rate (CRR)From first dose through completion of 5 cycles (cycle length = 21 days for cycles 1-4 and 14 days for cycle 5) of odronextamab and chimeric antigen receptor (CAR) T cell infusion
Will be assessed by Lugano 2014. Will calculate the uniformly minimum variance unbiased estimator, p-value, and confidence intervals for CRR. The calculation will be performed using R clinfun package.