Actively Recruiting
Odronextamab in Relapsed or Refractory Diffuse Large B-Cell Lymphoma Before and After CAR T-Cell Therapy
Led by Joseph Tuscano · Updated on 2025-09-29
34
Participants Needed
1
Research Sites
8 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
Researchers are evaluating how well odronextamab works when given before and after standard chimeric antigen receptor (CAR) T-cell therapy in patients with diffuse large B-cell lymphoma (DLBCL) that has returned after improvement or has not responded to previous treatments. This phase II trial aims to assess the anti-tumor activity and safety of combining odronextamab with CAR T-cell therapy in these patients. Odronextamab is a monoclonal antibody designed to help the immune system's T-cells target and destroy cancerous B-cells in DLBCL. Participants receive odronextamab intravenously over 1 to 4 hours on specific days during cycles that repeat every 21 days until a durable complete response is achieved, disease progresses, or unacceptable side effects occur. Those with a durable response may continue odronextamab on a 28-day cycle for up to two years. If after several cycles the disease has not fully responded or progresses, patients receive the standard CAR T-cell therapy. Throughout the study, patients undergo various scans and blood tests, including echocardiograms, PET/CT, and possibly brain CT. During the trial, participants have regular assessments including imaging and blood sample collection to monitor response and safety. After treatment ends, they are followed up at 30 days and then every four months for up to two years. The main outcome measured is the complete response rate after five treatment cycles, along with monitoring for side effects, progression-free survival, overall response, and minimal residual disease status.
CONDITIONS
Brief 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...
- Aged 18 years or older at 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
- Candidate for FDA-approved CAR T-cell therapy
- ECOG performance status of 2 or less (Karnofsky score 50% or higher)
- Leukocyte count at least 2,500/µL
- Absolute neutrophil count at least 1,000/µL (or >500/µL with bone marrow involvement)
- Platelet count at least 50,000/µL (or ≥25,000/µL with bone marrow involvement)
- Total bilirubin 1.5 times or less the institutional upper limit of normal (ULN)
- AST and ALT levels 3 times or less the ULN (5 times or less for liver involvement)
- Creatinine clearance at least 30 mL/min/1.73 m²
- Hemoglobin at least 8 g/dL (or ≥7 g/dL with bone marrow involvement)
- Alkaline phosphatase less than 2.5 times ULN (up to 5 times for liver or bone metastases)
- INR and aPTT 1.5 times or less ULN (for patients not on therapeutic anticoagulation)
- Cardiac ejection fraction greater than 50%
- Serum creatinine 1.5 times or less ULN or creatinine clearance at least 50 mL/min
- For HIV-positive patients: controlled infection, undetectable viral load, CD4+ T-cell count recovered to at least 250/mm³, and adherence to antiretroviral therapy
- Hepatitis B or C patients on suppressive therapy with negative viral load and no liver damage
- Use of adequate contraception for people of childbearing potential and partners during and for 6 months after study
- Able and willing to provide informed consent
You will not qualify if you...
- Any condition or lab abnormality posing unacceptable risk or interfering with data interpretation
- Known primary central nervous system lymphoma or uncontrolled non-primary CNS non-Hodgkin lymphoma involvement
- History within 12 months of CNS conditions such as epilepsy, severe brain injury, stroke, psychosis, or inflammatory brain lesions
- Another active cancer within 5 years except certain skin or cervical cancers effectively treated
- Active infection requiring treatment or with potential for severe disease at enrollment
- Active COVID-19 infection
- Uncontrolled HIV, hepatitis B, or hepatitis C infections
- Detectable cytomegalovirus (CMV) infection without successful treatment
- Use of systemic corticosteroids above specified doses within 72 hours before treatment
- Recent major surgery within 4 weeks before starting study treatment
- Radiotherapy within 14 days before 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 anti-cancer treatments except some maintenance therapies
- Uncontrolled systemic fungal, bacterial, or viral infections
- Pregnancy or breastfeeding
- Known allergies to allopurinol, rasburicase, or similar compounds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Cycles repeat every 21 days until durable complete response, disease progression, or unacceptable toxicity; followed by cycles every 28 days for up to 2 years if durable complete response is achieved.
Participants receive odronextamab intravenously over multiple cycles and may receive CAR T-cell therapy based on disease response.
Multiple visits for odronextamab infusions on specified days within each cycle; additional visits for CAR T-cell therapy if applicable
Duration - Up to 2 years after treatment completion
Participants are monitored after completion of study treatment to assess safety and disease status.
1 visit at 30 days post-treatment, then visits every 4 months
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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