Actively Recruiting
A Phase Ib Trial With Dose Expansion of Epcoritamab in Combination With Ibrutinib in Refractory/Recurrent Central Nervous System Lymphoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-06
26
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether the combination of two drugs, epcoritamab and ibrutinib, is a safe treatment for people with relapsed or refractory primary central nervous system lymphoma (PCNSL) or secondary central nervous system lymphoma (SCNSL). This phase 1b trial aims to find out if this treatment approach causes only few or mild side effects in these patients. The trial is led by Memorial Sloan Kettering Cancer Center and focuses on patients with these specific lymphoma types who have not responded to previous treatments or whose disease has returned. Participants will receive epcoritamab as a subcutaneous injection at the study clinic and ibrutinib as a daily self-administered oral medication taken at about the same time each day. The study includes different patient cohorts with relapsed or refractory PCNSL. The treatment period is followed by monitoring for dose-limiting toxicities over an 8-week period to assess safety. The study does not involve a placebo group and is not randomized, focusing on evaluating the combination's tolerability. During the study, participants will have regular assessments including scans like MRI or CT to monitor disease, laboratory tests to check blood counts and organ function, and pregnancy tests for women of childbearing potential. Safety is closely monitored through these tests and patient reports of side effects. The main outcome measured is the number of dose-limiting toxicities within 8 weeks after starting treatment. Participants will be followed throughout the treatment and safety monitoring periods until the study ends in 2028.
CONDITIONS
Brief Title
A Study of Epcoritamab and Ibrutinib in People With Central Nervous System Lymphoma (CNSL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older at the time of consenting to the study
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL) from biopsy or cerebrospinal fluid samples in PCNSL, or biopsy of CNS or non-CNS sample in SCNSL
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Adequate bone marrow and organ function including:
- Absolute neutrophil count ≥ 1 x 10^9/L
- Platelets ≥ 75 x 10^9/L with no platelet transfusion in past 21 days
- Hemoglobin ≥ 8 g/dL with no red blood cell transfusion in past 21 days
- INR ≤ 1.5 and PTT ≤ 1.5 times upper limit unless on anticoagulation
- ALT and AST ≤ 3 times upper limit
- Serum bilirubin ≤ 1.5 times upper limit or total bilirubin ≤ 3 times upper limit with normal direct bilirubin in Gilbert Syndrome
- Creatinine clearance ≥ 30 ml/min
- Women of reproductive potential must agree to use highly effective birth control during and 30 days after therapy; men must use contraception during and 3 months after therapy
- Female participants of childbearing potential must have a negative serum pregnancy test before study entry
- Ability to tolerate MRI or CT scans
- Patients with impaired decision-making ability may enroll
You will not qualify if you...
- Newly diagnosed PCNSL or SCNSL, or patients with non-CNS disease
- Moderate or severe chronic liver impairment (Child-Pugh class B or C)
- Concurrent use of other approved or investigational anticancer agents
- Active concurrent malignancy requiring therapy
- Recent chemotherapy, monoclonal antibodies, targeted therapy, or radiation to CNS within specified time frames
- Requirement of more than 8 mg daily dexamethasone or equivalent
- Use of warfarin or warfarin-derivative anticoagulants within seven days before study
- Consumption of grapefruit, Seville oranges, or starfruit within 3 days before treatment
- Use of moderate or strong CYP3A inhibitors or inducers not stopped for required washout period
- Use of systemic immunosuppressants or chronic prednisone >5 mg/day within specified washout
- Significant abnormal EKG or active cardiovascular disease
- Ejection fraction below 50%
- Known bleeding disorders like hemophilia or von Willebrand's disease
- Known HIV infection
- Active or chronic hepatitis B or C infection
- Uncontrolled active systemic infection
- Inability to swallow capsules or significant gastrointestinal disease
- Life-threatening illness or organ dysfunction affecting safety
- Recent live vaccinations or planned live vaccines during study participation
- Pregnant or nursing women
- Women must meet specific criteria to be considered not of childbearing potential including menopause or surgical sterilization
- Fertile males must use condoms and partners must use contraception during and after study therapy
- No active severe SARS-CoV-2 infection confirmed by testing
- COVID-19 vaccines permitted with timing recommendations related to study drug administration
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 8 weeks
Participants receive Epcoritamab injections at the study site and self-administer daily oral ibrutinib to treat their lymphoma.
Multiple clinic visits for Epcoritamab injections and daily oral medication at home
Trial Site Locations
Total: 8 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
8
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
C
Christian Grommes, MD
L
Lauren Schaff, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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