Actively Recruiting
Epcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma
Led by Yazeed Sawalha · Updated on 2026-02-19
38
Participants Needed
2
Research Sites
195 weeks
Total Duration
On this page
Sponsors
Y
Yazeed Sawalha
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase Ib/II trial evaluates the safety, optimal dose, and efficacy of the combination of epcoritamab and ibrutinib in treating patients with aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or responded to previous treatment (refractory). Epcoritamab, a bispecific antibody, binds to two different types of receptors (proteins present on the cell surface) at the same time. The two receptors that epcoritamab binds to are called CD3 and CD20. CD3 is found on T cells, which are important cells of the immune system that help fight cancer and infections. CD20 is found on the surface of most types of aggressive B-cell non-Hodgkin lymphoma cells. By binding to both CD3 and CD20, epcoritamab brings the two cells close together so the T cells can fight and kill the lymphoma B cells. Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, binds to a protein on B cells, a type of white blood cell from which the lymphoma developed. By doing this it decreases the ability of the lymphoma B cells to survive and grow. Ibrutinib may also improve the health (or fitness) of T cells thus making epcoritamab safer and/or more effective.
CONDITIONS
Official Title
Epcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with one of the following CD20-positive B-cell non-Hodgkin lymphoma types: diffuse large B-cell lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, primary mediastinal B-cell lymphoma, or follicular lymphoma grade 3b
- Previously diagnosed indolent lymphoma transformed into one of the above lymphoma types
- Relapsed or refractory aggressive B-cell lymphoma with prior anthracycline and anti-CD20 antibody treatment
- At least two prior systemic lymphoma treatments, or one prior treatment if high-risk disease and ineligible for CAR T-cell therapy
- Prior BTK inhibitor treatment allowed if stopped due to progression or completion, not intolerance
- Prior autologous stem cell transplant at least 100 days before enrollment
- Prior CAR T-cell therapy at least 30 days before enrollment
- Age 18 years or older
- ECOG performance status of 0 to 2
- Measurable disease greater than 1.5 cm or at least one PET FDG-avid disease area
- Absolute neutrophil count at least 1,000/mcL
- Platelet count at least 75,000/mcL (50,000/mcL allowed if bone marrow involvement or splenomegaly present)
- Hemoglobin level at least 8 g/dL
- No recent transfusion or growth factor support within 7 days (14 days if long-acting growth factors) before enrollment
- Total bilirubin at or below 1.5 times upper normal limit (or below 3 if due to Gilbert's disease or hemolysis)
- AST and ALT less than 3 times institutional upper normal limit
- Creatinine clearance above 45 mL/min; not on dialysis
- Agreement to use contraception or abstinence during and for 12 months after treatment if of childbearing potential
- Negative pregnancy test for women of childbearing potential at screening
- Ability and willingness to provide informed consent
You will not qualify if you...
- Prior therapy with bispecific antibody targeting CD3 and CD20
- Recent lymphoma therapy within 2 weeks before starting study (except corticosteroids for symptom relief)
- Need for immediate lymphoma cytoreductive therapy
- History of allogeneic stem cell transplant within 180 days or with active graft versus host disease or recent immunosuppressive medication
- Ongoing treatment with strong CYP3A inhibitors or inducers
- Major surgery within 4 weeks before treatment start except diagnostic surgery
- Active central nervous system lymphoma involvement
- Active uncontrolled infections requiring IV antibiotics within 2 weeks before treatment
- Uncontrolled or symptomatic cardiovascular conditions including recent heart attack, unstable angina, or severe heart failure
- Known moderate to severe liver cirrhosis
- Significant pulmonary disease or history of severe bronchospasm or lung inflammation
- Recent stroke or transient ischemic attack within 6 months
- History of intracranial hemorrhage
- Significant bleeding disorders
- Receiving warfarin or coumadin
- Gastrointestinal conditions interfering with oral drug absorption or inability to swallow pills
- Serious medical or psychiatric illnesses interfering with study treatment
- Known allergy to study drugs or their components
- Prior solid organ transplant
- Other malignancies affecting study compliance or results
- Participation in other interventional trials within 21 days before study
- Known HIV infection or active hepatitis B or C infections
- Pregnant or breastfeeding women
- Ongoing significant toxicity from prior treatments at grade 2 or higher
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
2
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
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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