Actively Recruiting
Phase Ib/II Trial of Epcoritamab Plus Ibrutinib in Patients With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin Lymphoma
Led by Yazeed Sawalha · Updated on 2026-06-04
38
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
Sponsors
Y
Yazeed Sawalha
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, best dose, and effectiveness of combining epcoritamab and ibrutinib to treat patients with aggressive B-cell non-Hodgkin lymphoma that has returned or not responded to previous treatments. Epcoritamab is a bispecific antibody that connects immune T cells to lymphoma B cells to help the immune system attack the cancer. Ibrutinib blocks signals that help lymphoma B cells survive and grow, and it may also improve T cell function to support epcoritamab's action. Participants take ibrutinib by mouth daily starting one week before the first treatment cycle and continuing through up to six 28-day cycles. Epcoritamab is given as a subcutaneous injection on specific days during up to 12 cycles, with treatment continuing unless disease progresses or side effects become unacceptable. Patients also undergo blood tests, CT scans, PET/CT scans, and may have bone marrow samples taken during the study. After treatment ends, patients are followed every three months for two years, then every six months for up to five years. During the study, researchers monitor safety by tracking side effects and a specific immune reaction called cytokine release syndrome. They evaluate treatment response using imaging and clinical criteria, including complete and overall response rates, progression-free and overall survival, and duration of response. Blood and tumor samples are analyzed to understand immune effects, tumor environment, and disease markers. The total participation may last several years due to long-term follow-up visits.
CONDITIONS
Brief 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 a CD20-positive aggressive B-cell non-Hodgkin lymphoma subtype such as diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, or grade 3b follicular lymphoma
- Relapsed or refractory aggressive B-cell lymphoma with prior treatment including an anthracycline plus anti-CD20 antibody
- Received at least two prior systemic lymphoma treatments, or at least 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 allowed if at least 100 days before enrollment
- Prior CAR T-cell therapy allowed if at least 30 days before enrollment
- Age 18 years or older
- ECOG performance status 0 to 2
- Measurable disease or PET scan showing active lymphoma
- Adequate blood counts: neutrophils ≥1,000/mcL, platelets ≥75,000/mcL (≥50,000/mcL if bone marrow involvement), hemoglobin ≥8 g/dL
- Liver and kidney function within specified limits
- Use of effective contraception for men and women of childbearing potential during and after the study
- Negative pregnancy test for women of childbearing potential
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Prior therapy with bispecific antibody targeting CD3 and CD20
- Lymphoma therapy within 2 weeks before starting the study except corticosteroids for symptom relief
- Need for immediate cytoreductive therapy
- History of allogeneic stem cell transplant within 180 days or active graft versus host disease
- Use of strong CYP3A inhibitors or inducers within 5 half-lives before treatment
- Major surgery within 4 weeks before treatment start
- Known active central nervous system lymphoma involvement
- Active uncontrolled infection requiring intravenous antibiotics
- Uncontrolled or symptomatic heart conditions or recent heart attack
- Liver cirrhosis with moderate to severe impairment
- Significant lung disease or history of severe bronchospasm
- Recent stroke or transient ischemic attack
- History of intracranial bleeding
- Significant bleeding disorders or use of warfarin
- Gastrointestinal issues interfering with oral drug absorption
- Serious medical or psychiatric illness affecting treatment completion
- Allergy to study medications or ingredients
- Prior solid organ transplant
- Other malignancies affecting study compliance
- Participation in other interventional trials within 21 days
- Active hepatitis B or C or HIV infection
- Pregnant or breastfeeding women
- Ongoing significant toxicity from prior therapy Grade 2 or higher
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 - Up to 12 cycles of 28 days each
Participants receive ibrutinib orally once daily and epcoritamab subcutaneously on a schedule over multiple 28-day cycles. Treatment continues for up to 6 cycles of ibrutinib and up to 12 cycles of epcoritamab unless there is disease progression or unacceptable toxicity. Blood samples, CT scans, and PET/CT scans are collected throughout treatment, and bone marrow aspiration and biopsy may also occur.
Multiple visits for drug administration and assessments each cycle during treatment
Duration - Up to 5 years
After completing treatment, participants are followed up every 3 months for 2 years, then every 6 months for up to 5 years to monitor health and disease status.
Visits every 3 months for 2 years, then every 6 months for up to 5 years
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
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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