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Epcoritamab for Adults with Relapsed or Refractory Marginal Zone Lymphoma: A Phase II Open‑Label Study

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

Marginal Zone Lymphoma is a rare type of blood cancer that starts in the immune system’s white‑blood cells. In some people the disease comes back after treatment or does not respond to the medicines that were tried before; this is called “relapsed or refractory.” The study uses a medication called epcoritamab, which is given as a subcutaneous injection (a shot under the skin) in two possible strengths.

The aim of the trial is to see how well the drug works and how safe it is for people with this kind of cancer. Participants will receive the injection regularly over a period that can include up to 12 treatment cycles, with clinic visits to check for any side effects and to see if the cancer is shrinking or disappearing. Doctors will look for a “complete remission,” meaning no signs of disease, as well as overall response, which includes any reduction in tumor size. Throughout the study, patients’ quality of life and any new health problems will also be recorded.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    First dose administration

    You receive the initial epcoritamab injection, supplied as tepkinly 4 mg/0.8 ml solution for injection.

    The drug is given by subcutaneous injection, which means it is placed just under the skin.

    The dose contains 4 mg (milligrams) of the active substance.

    The injection is performed by study staff according to the study schedule.

  2. Step 2

    Subsequent dose administration

    After the initial dose, you receive further injections of epcoritamab using tepkinly 48 mg solution for injection.

    Each of these injections contains 48 mg of the drug.

    The injections are also given by subcutaneous injection.

    The injections are repeated for up to 12 treatment cycles as defined by the study protocol. a cycle is a set period of treatment defined by the investigators.

  3. Step 3

    Regular monitoring visits

    Throughout the treatment period you attend scheduled clinic visits.

    During each visit study staff check your health, record any side effects, and may take blood samples to monitor how your body is responding.

    These checks help ensure the safety of the treatment and allow adjustments if needed.

  4. Step 4

    Completion of treatment

    Treatment ends after you have completed the 12th cycle, or earlier if the investigator decides to stop the study drug for any reason.

    Four weeks after the last injection a final assessment is performed to determine the primary outcome, which is the rate of complete remission (no detectable disease).

  5. Step 5

    Post‑treatment follow‑up

    After the final assessment you continue to be followed for additional outcomes such as overall response, time to disease progression, and overall survival.

    Follow‑up visits may include further health checks and questionnaires about quality of life.

Who can join the trial?

20 criteria

  • You have a confirmed diagnosis of Marginal Zone Lymphoma (MZL) that was verified by a specialist pathology center, and a tumor tissue sample (biopsy) taken within the last 12 months is required.
  • The lymphoma must be CD20‑positive and must have come back (relapsed) or not responded (refractory) after earlier treatment, including any of the following forms: extranodal, splenic, or nodal MZL.
  • If you are a man, you must agree not to father a child during the study treatment and for four months after the last dose, and you must advise your partner to use a highly effective birth‑control method; you must also use condoms.
  • You must have disease that can be measured, meaning at least one tumor or affected area that can be sized on imaging: a lymph node larger than 1.5 cm, an organ lesion larger than 1.0 cm on CT/PET‑CT/MRI, an enlarged spleen over 13 cm, or a stomach lesion seen on endoscopy.
  • You must be willing and able to attend all scheduled study visits, receive the study drug, undergo imaging scans, give blood and other laboratory samples, and follow any study‑specific rules.
  • You must sign an informed consent form showing that you understand the disease, the experimental nature of the treatment, possible benefits, risks, side effects, and alternative options.
  • You need to have symptoms that require systemic (whole‑body) treatment for your lymphoma.
  • You must have received at least one anti‑CD20 monoclonal antibody therapy (such as rituximab) for at least two treatment cycles, unless it was stopped early because the disease got worse or side effects were unacceptable. You also must not have achieved at least a partial response (some shrinkage of the tumor) or must have shown disease progression after the most recent therapy. Treatments that only target the stomach bacteria *Helicobacter pylori* or local radiation do not count.
  • You must be 18 years of age or older.
  • Your doctors must expect you to live at least three more months.
  • Your blood platelet count must be greater than 50 × 10⁹/L (unless low because the cancer has invaded the bone marrow).
  • Your absolute neutrophil count (a type of white blood cell) must be greater than 1 × 10⁹/L (unless low because of bone‑marrow involvement).
  • The number of circulating lymphocytes must be less than 25 × 10⁹/L.
  • Your hemoglobin level (the protein that carries oxygen) must be at least 8.0 g/dL (or 5.6 mmol/L) without needing medication to boost red cells or a blood transfusion in the past two weeks.
  • Liver enzyme levels (ASAT/SGOT and ALAT/SGPT) must be less than three times the normal laboratory limit (or less than five times if the lymphoma involves the liver).
  • Your total bilirubin (a waste product processed by the liver) must be no more than 1.5 times the upper normal limit, or direct bilirubin no more than 2 times the limit if total bilirubin is higher.
  • Your kidney function must be adequate: serum creatinine must be no more than 1.5 times the upper normal limit, or you must have a glomerular filtration rate (GFR) of at least 50 mL/min.
  • Your blood fibrinogen (a protein needed for clotting) must be at least 1 g/L.
  • If you are a woman who could become pregnant, a pregnancy test (β‑HCG) must be negative at screening and at the start of the study.
  • Women of child‑bearing potential must agree to use a highly effective birth‑control method (such as hormonal pills, implants, IUD, sterilization, or abstinence) and to have a monthly pregnancy test during treatment and for four months after the last dose.

Who cannot join the trial?

24 criteria

  • ECOG performance status of 3 or higher (a score that shows the person is very limited in daily activities) excludes participation.
  • A past or current history of non‑infectious pneumonitis (lung inflammation not caused by infection) that needed steroid medication makes a person ineligible.
  • Any previous severe allergic reaction (anaphylaxis) to monoclonal antibodies, or a severe (grade 3 or higher) allergy to the study drug or its ingredients, excludes enrollment.
  • Having had another type of cancer (non‑lymphoid) in the past, except for certain early‑stage skin cancers, early‑stage bladder cancer, in‑situ cervical cancer, low‑risk prostate cancer, or other stage 1 cancers that have been cured and remain in remission for at least three years, will disqualify a participant.
  • Active autoimmune disease (where the immune system attacks the body) that required strong systemic treatment (such as disease‑modifying drugs, high‑dose steroids, or immunosuppressants) within the last two years is an exclusion. Small doses of steroids (<20 mg prednisone daily) and inhaled steroids are allowed.
  • A known history of tuberculosis (TB) excludes participation.
  • Current alcohol or drug addiction, or serious psychiatric or substance‑abuse problems that would prevent following the study requirements, are grounds for exclusion.
  • Previous diagnosis of Stevens‑Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN) (severe skin reactions) disqualifies a person.
  • Having lymphoma in the brain or spinal fluid (central nervous system lymphoma), or cancer that has changed into a high‑grade or diffuse large B‑cell lymphoma, excludes enrollment.
  • Receiving chemotherapy or targeted cancer drugs within 28 days before the first study dose, or not having recovered from related side effects (must be grade 1 or lower), makes a person ineligible.
  • Prior treatment with a bi‑specific anti‑CD20×CD3 antibody (a specific type of experimental therapy) disqualifies participation.
  • Being pregnant or breastfeeding excludes a person from the trial.
  • Use of any other experimental drug, or participation in another clinical trial, within 4 weeks before starting this study (or longer if the other drug stays in the body for a long time) is not allowed.
  • Radiation therapy received within 2 weeks before the first study dose excludes a participant.
  • Any ongoing systemic infection (bacterial, fungal, or viral) at the time of screening, such as cytomegalovirus (CMV), HIV, or COVID‑19, makes a person ineligible.
  • Current liver problems, including drug‑induced liver injury, active hepatitis B, alcoholic liver disease, non‑alcoholic fatty liver disease, primary biliary cholangitis, bile‑duct blockage from gallstones, cirrhosis, or high blood pressure in the liver’s portal vein, exclude enrollment.
  • Known HIV infection, active hepatitis C, active hepatitis B, or any uncontrolled infection that needs intravenous antibiotics excludes participation. People who have been vaccinated against hepatitis B and show only immunity are allowed, but anyone with a positive PCR test for hepatitis B or C is excluded.
  • Significant heart disease, such as a heart attack within the past year, stroke within the past six months, unstable chest pain (unstable angina), heart failure worse than NYHA class II, uncontrolled heart rhythm problems (arrhythmia), or other serious heart test abnormalities, disqualifies a participant.
  • Uncontrolled high blood pressure (hypertension) despite best medical treatment excludes enrollment.
  • Any other serious illness, medical condition, previous surgery, abnormal test result, or laboratory finding that the doctor believes could affect safety or study results makes a person ineligible.
  • Receiving a live vaccine (such as measles, mumps, rubella) within 30 days before starting the study drug excludes participation.
  • Recent clotting events, such as stroke, transient ischemic attack (mini‑stroke), deep‑vein thrombosis, or pulmonary embolism, within the past three months, disqualify a participant.
  • Severe lung disease that limits breathing (severe interstitial lung disease or markedly reduced lung function) excludes enrollment.
  • Active spread of cancer to the brain or its covering (CNS metastases or carcinomatous meningitis) excludes participation. People with previously treated brain metastases may be allowed only if the lesions have been stable on scans for at least four weeks and no steroids have been needed for two weeks.
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Investigated drugs

Tepkinly (epcoritamab) is a medication given as a liquid that is injected under the skin. It is designed to help the immune system recognize and attack cancer cells in people whose marginal‑zone lymphoma has come back or did not respond to earlier treatments. In this study, participants receive the medication to see how well it can shrink or eliminate the lymphoma and to monitor any side effects, changes in quality of life, and any new cancers that might develop during treatment.

What is already known about the treatment

  • Tepkinly 4 mg/0.8 ml solution for injection

    The medication is supplied as a clear solution for subcutaneous injection, which is administered under the skin. It is currently an investigational drug being studied in clinical trials and has not yet received general market approval. It is being tested for people with relapsed or refractory marginal zone lymphoma, a type of blood cancer. The drug is a bispecific antibody that connects T‑cells (via CD3) to cancer B‑cells (via CD20) so the immune system can destroy the tumor, and it belongs to the class of immunotherapy bispecific T‑cell engagers.

  • Tepkinly 48 mg solution for injection

    This product is also a clear solution given by subcutaneous injection, placed just under the skin. It remains an investigational therapy in clinical studies and is not yet approved for routine clinical use. The treatment is aimed at patients with relapsed or refractory marginal zone lymphoma. It works as a bispecific antibody that links T‑cells (through CD3) to malignant B‑cells (through CD20) to trigger immune‑mediated killing, and it is classified as an immunotherapy bispecific T‑cell engager.

Investigated diseases

Marginal Zone Lymphoma - Marginal Zone Lymphoma is a type of blood cancer that starts in B‑cells located in the outer part of lymph nodes, spleen, or the lining of the gut. It grows slowly and often causes painless swelling of lymph nodes or the spleen. Over time the abnormal cells can spread to the bone marrow and blood. Some people notice feeling tired or a mild fever as the disease expands. The condition may remain stable for months or years before showing more noticeable changes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524879-23-00Protocol codeEPOS-1Estimated enrolment53 patientsSponsorUniversitaetsklinikum Ulm AöR

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