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A Study of MK-1045 for Non-Hodgkin Lymphoma

This study is testing a new treatment called MK-1045 for two types of non-Hodgkin lymphoma (NHL): follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). NHL is a cancer of the immune system. MK-1045 is an immunotherapy, meaning it helps your immune system fight cancer. Researchers want to see how safe MK-1045 is, how well people tolerate it, and if it can make the cancer shrink or go away. You may be able to join if you are 18 or older, have FL or DLBCL that has come back or not responded to at least two previous treatments. The study aims to enroll about 200 participants. The current status of the study is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll about 200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events for up to approximately 44 months, and for treatment discontinuation due to adverse events for up to approximately 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07519772

A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~280 participants
Updated 2026-09-11 on ClinicalTrials.gov
What's tested:MK-1045

At a glance

Recruiting sites
39 of 39 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Who Experience an Adverse Event (AE)
Measured over Up to approximately 49 months
+3 more outcomes measured

Conditions

Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Lymphoma, Large B-Cell, Diffuse

Explore related trials

Diffuse Large B-Cell LymphomaFollicular Lymphoma

NCT07519772

Where you'd take part

This study runs at 39 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Antalya Egitim ve Arastirma Hastanesi ( Site 1003)

    Antalya, Turkey (Türkiye)study coordinator listed

    Recruiting

  • Beijing Cancer hospital ( Site 1701)

    Beijing, Beijing Municipality, Chinastudy coordinator listed

    Recruiting

  • Box Hill Hospital ( Site 0202)

    Box Hill, Victoria, Australiastudy coordinator listed

    Recruiting

  • Carmel Hospital ( Site 0602)

    Haifa, Israelstudy coordinator listed

    Recruiting

  • Clínica Alemana de Santiago ( Site 1608)

    Santiago, Region M. de Santiago, Chilestudy coordinator listed

    Recruiting

  • Colorado Blood Cancer Institute ( Site 7000)

    Denver, Coloradostudy coordinator listed

    Recruiting

  • Derriford Hospital ( Site 1304)

    Plymouth, Devon, United Kingdomstudy coordinator listed

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli ( Site 0705)

    Roma, Italystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Participants Who Experience an Adverse Event (AE)Up to approximately 49 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

  • Number of Participants Who Discontinue Study Treatment Due to an AEUp to approximately 12 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

  • Arms 2 and 3: Number of Participants Who Experience Dose Limiting Toxicity (DLT)Up to approximately 28 days

    DLT will be defined as any drug-related AE observed during the DLT evaluation period (up to 28 days) that results in a change to a given dose or a delay in initiating the next treatment.

  • Arms 1, 2, and 4: Objective Response Rate (ORR) per Lugano Response Criteria as assessed by Blinded Independent Central review (BICR)Up to approximately 49 months

    ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and will be evaluated using computed tomography (CT) and positron emission tomography (PET)-CT. Response will be assessed based on the International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose \[FDG\] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). In Arms 1, 2, and 4, the percentage of participants who experience CR or PR as assessed by BICR will be presented.