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RecruitingLast updated: 7 August 2026

MK-1045-008: Testing an immunotherapy treatment called MK-1045 in people with relapsed or refractory follicular lymphoma or diffuse large B-cell lymphomaA Phase 1b/2 Study to Evaluate the Safety and Efficacy of MK-1045 Monotherapy or in Combination With Other Anticancer Agents in Participants With Non-Hodgkin Lymphoma

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

MK-1045-008

Clinical summary

Summary

Researchers are looking at a new treatment for people with two types of non-Hodgkin lymphoma (NHL):

  • follicular lymphoma (FL) and
  • diffuse large B-cell lymphoma (DLBCL).

NHL is a cancer of the lymphatic system, which is part of the body's immune system and helps fight infection. People with NHL may develop swollen lymph nodes and other symptoms. FL is usually a slow-growing form of NHL, while DLBCL tends to grow more quickly.

This study is testing a new immunotherapy called MK-1045. Immunotherapy works by helping the body's immune system recognise and gith cancer cells.

Researchers want to find out:

  • How safe MK-1045 is
  • What side effects people may experience
  • How well people can tolerate the treatment
  • Whether MK-1045 can help shrink the lymphoma or make it disappear

Participants may receive MK-1045 on its own or in combination with other anti-cancer treatments.

Conditions

This trial is treating people with relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma

Eligibility

Inclusion

The main inclusion criteria include but are not limited to the following:

  • Has disease that has relapsed (disease progression after remission) or is refractory (failure to achieve complete or partial response) to at least 2 prior systemic lines of therapy.
  • Has a histologically confirmed diagnosis of follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL).
  • DLBCL participants only: has progressed after or is ineligible for transplant and chimeric antigen receptor T (cell) (CAR-T) therapy.
  • Has provided tumor tissue sample (archival or newly obtained, if performed per standard of care).
  • Has documented retained expression of cluster of differentiation 19 (CD19) in tumor tissue obtained by biopsy after disease progression on CD19-targeting therapy, if experienced disease progression after prior CD19-targeting therapy.
  • Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if has a history of HIV infection.
  • Has undetectable hepatitis B virus (HBV) viral load and received and will continue to receive HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.
  • Has undetectable hepatitis C virus (HCV) viral load and received HCV antiviral therapy if has a history of HCV infection.
  • Has radiographically measurable disease per Lugano Response Criteria.

Exclusion

The main exclusion criteria include but are not limited to the following:

  • Has received a solid organ transplant.
  • Had or has clinically relevant central nervous system (CNS) diseases.
  • Has a history of serious cardiovascular or cerebrovascular diseases.
  • Had prior allogenic stem cell transplantation with acute graft-versus-host-disease (GVHD); has ongoing evidence of chronic GVHD manifesting as skin involvement, diarrhea, or increased serum bilirubin; or requires systemic immunosuppression for GVHD.
  • Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
  • Has received a live or live-attenuated vaccine within 30 days of randomization.
  • Has received prior CAR-T therapy within 3 months before the first dose of the study intervention.
  • Has a known additional malignancy that is progressing or required active treatment within the past 2 years.
  • Has known active CNS lymphoma or involvement.
  • Has active autoimmune disease that required systemic treatment in the past 2 years.
  • Has active infection requiring systemic therapy.
  • Has a history of severe bleeding disorders.
  • Has not recovered from major surgery or has ongoing surgical complications.
  • Has diagnosis of primary mediastinal B-cell lymphoma.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT07519772 *
  • 2025-523005-15-00 *
  • 1045-008; U1111-1324-8720

Trial sponsor

Merck Sharp & Dohme LLC

Scientific Title

A Phase 1b/2 Study to Evaluate the Safety and Efficacy of MK-1045 Monotherapy or in Combination With Other Anticancer Agents in Participants With Non-Hodgkin Lymphoma

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