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Study of MK-1045 alone or with Tocilizumab in patients with Non‑Hodgkin Lymphoma to evaluate safety and efficacy

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What is this trial about?

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

Non-Hodgkin Lymphoma is a type of blood cancer that starts in the lymphatic system, which helps fight infection. The study is testing a new medicine called MK-1045. This drug may be given directly into a vein (intravenous) or injected under the skin (subcutaneous), and in some groups it may be combined with other cancer medicines.

The main aim of the study is to find out whether the medicine is safe and can help shrink or control the cancer. Participants will be placed into different groups that receive the drug in one of the ways described, and they will have regular visits where doctors check for side effects, take blood samples, and perform imaging scans to see how the disease is responding. The study will follow each person for several months to monitor health and any changes in the cancer.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Consent and enrollment

    After joining the study you will read a detailed information sheet and sign a consent form that explains the purpose of the trial and your rights.

    Your participation is recorded and you become an enrolled participant for the study.

  2. Step 2

    Baseline assessments

    The study team will collect your medical history, perform physical examinations, and take blood samples to evaluate organ function.

    Imaging tests such as scans will be done to document the extent of non-hodgkin lymphoma before treatment begins.

  3. Step 3

    First dose of <b>mk-1045</b>

    You will receive the first administration of mk-1045 according to the arm you are assigned to.

    If you are in arm 1, 2, or 4 the drug is given by intravenous (iv) infusion; if you are in arm 3 it is given by subcutaneous (sc) injection.

    The exact dose amount, infusion rate, and injection volume are defined by the study protocol and will be followed by the clinical staff.

  4. Step 4

    Continued treatment cycles

    Additional doses of mk-1045 are given at regular intervals set by the protocol, typically every few weeks.

    Each cycle includes the same method of administration (iv or sc) as the first dose and continues for the number of cycles specified in the study plan.

  5. Step 5

    Safety monitoring

    Before each dose you will have vital signs checked and blood drawn to monitor organ function.

    The study staff will ask about any new symptoms and record any adverse events that occur.

    If a serious problem such as dose limiting toxicity (dlt) is identified, treatment may be paused or stopped according to protocol guidelines.

  6. Step 6

    Efficacy evaluation

    Periodic imaging scans are performed to assess tumor response using the lugano response criteria.

    In arms 1 and 4 the response is reviewed by a blinded independent central review, while in arms 2 and 3 the investigator or designated reviewer evaluates the results.

    The primary measurement of effectiveness is the objective response rate (orr), and the length of time the response lasts is called the duration of response (dor).

  7. Step 7

    Treatment completion

    Treatment ends after the pre‑specified number of cycles have been administered or earlier if a discontinuation criterion such as an adverse event is met.

    A final set of safety labs and imaging studies is performed to document the status at the end of treatment.

  8. Step 8

    Post‑treatment follow‑up

    After treatment stops you will continue to have regular visits for safety checks and to monitor disease status.

    Follow‑up visits may include blood tests and imaging at intervals defined by the protocol, extending for several weeks or months after the last dose.

Who can join the trial?

11 criteria

  • Must have Non‑Hodgkin Lymphoma that has come back (relapsed) or did not respond (refractory) after at least two different rounds of standard drug treatment.
  • Must have a diagnosis confirmed by looking at tissue under a microscope that the cancer is either follicular lymphoma or diffuse large B‑cell lymphoma (DLBCL).
  • If the cancer is DLBCL, you must have either progressed after a stem‑cell transplant or not be able to receive a transplant, and you must also have tried or be unable to receive CAR‑T cell therapy (a type of treatment that uses modified immune cells).
  • Must have provided a sample of tumor tissue (either from past records or a new biopsy done as part of regular care).
  • If you have previously received a treatment that targets CD19 (a protein on the cancer cells) and the disease got worse, a new biopsy must show that the tumor still has CD19 present.
  • If you have a history of HIV, the virus must be well‑controlled while you are on antiretroviral therapy (medications that keep HIV suppressed).
  • If you test positive for hepatitis B surface antigen (HBsAg), the hepatitis B virus must have an undetectable amount in your blood and you must be taking and continue to take hepatitis B antiviral medication.
  • If you have a history of hepatitis C, the hepatitis C virus must be undetectable in your blood and you must be receiving hepatitis C antiviral treatment.
  • You must have disease that can be measured on imaging scans according to the Lugano Response Criteria (a set of rules doctors use to assess lymphoma size and changes).
  • Both men and women are eligible to join the study.
  • People of any age group are allowed to participate.

Who cannot join the trial?

14 criteria

  • Has received a solid organ transplant – receiving a new kidney, liver, heart, or similar organ.
  • Has active autoimmune disease that required systemic treatment in the past 2 years – an immune system disorder that attacks the body and needed medicines that work throughout the whole body.
  • Has an active infection requiring systemic therapy – an infection that needs pills or IV medicines that affect the whole body.
  • Has a history of severe bleeding disorders – conditions that make it hard for blood to clot.
  • Has not recovered from major surgery or has ongoing surgical complications – has not healed after a big operation.
  • Has a diagnosis of primary mediastinal B‑cell lymphoma – a specific type of blood cancer located in the chest area.
  • Had or has clinically relevant central nervous system (CNS) diseases – problems affecting the brain or spinal cord that need medical attention.
  • Has a history of serious cardiovascular or cerebrovascular diseases – serious heart or brain blood‑vessel problems.
  • Had prior allogenic stem cell transplantation with acute graft‑versus‑host disease (GVHD); has ongoing evidence of chronic GVHD showing skin problems, diarrhea, or increased liver bilirubin; or needs medicines that suppress the immune system for GVHD.
  • Is HIV‑infected with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease – has the HIV virus and previously had a type of skin tumor (Kaposi’s sarcoma) or a rare disorder causing enlarged lymph nodes (Multicentric Castleman’s Disease).
  • Has received a live or live‑attenuated vaccine within 30 days of randomization – got a vaccine that contains a weakened germ within the past month.
  • Has received prior CAR‑T therapy within 3 months before the first dose of the study drug – had a special cell‑based cancer treatment within three months before starting the study medication.
  • Has a known additional malignancy that is progressing or required active treatment within the past 2 years – has another cancer that is getting worse or needed treatment in the last two years.
  • Has known active CNS lymphoma or involvement – has lymphoma (cancer of the lymph system) that is present in the brain or spinal cord.
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Investigated drugs

  • Tocilizumab

    is a medication that blocks a protein called interleukin‑6, which can help reduce inflammation. In this study it is mentioned as a background reference, meaning it is not the main drug being tested but is provided for context about other treatments that affect the immune system.

  • MK-1045

    is an experimental therapy being studied for people with Non‑Hodgkin Lymphoma. It is given either by an intravenous (IV) infusion or a subcutaneous (under the skin) injection. The trial is looking at how safe it is, how well patients can tolerate it, and whether it can shrink or control the cancer. The drug is tested alone, without other cancer medicines, to see its direct effect on the disease.

What is already known about the treatment

TOCILIZUMAB - This drug is given by injection into a vein (IV) or under the skin (SC) as a sterile solution. It is an approved medicine that is listed in medical literature for treating rheumatoid arthritis, certain types of arthritis, and severe immune reactions such as cytokine release syndrome. It works by attaching to the body’s interleukin‑6 (IL‑6) receptor, stopping the signal that causes inflammation. It belongs to the class of monoclonal antibodies and is used as an immunosuppressive therapy. MK-1045 - MK‑1045 is supplied as a clear solution for infusion that can be given intravenously (IV) or as a subcutaneous (SC) injection, depending on the study arm. It is currently an experimental drug that has not yet received regulatory approval and is being studied in early‑phase cancer trials. The medication is being tested for the treatment of Non‑Hodgkin lymphoma and works by blocking a key growth signal inside cancer cells, which helps slow or stop tumor growth. It is classified as an investigational anticancer agent, likely a small‑molecule inhibitor.

Investigated diseases

Non-Hodgkin Lymphoma - A type of cancer that begins in the white‑blood cells of the lymphatic system, which helps fight infection. It usually starts in lymph nodes but can also arise in the spleen, bone marrow, or other organs. The abnormal cells multiply and form tumors that may enlarge the affected lymph nodes. Over time the disease can spread to nearby tissues or distant parts of the body. The speed of growth can vary, with some forms progressing slowly and others advancing more quickly. Symptoms often develop as the tumors enlarge or affect organ function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-523005-15-00Protocol codeMK-1045-008Estimated enrolment212 patientsSponsorMerck Sharp & Dohme LLC

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).