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

Last updated: July 1, 2026
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

1/2

Condition

Follicular Lymphoma

Treatment

MK-1045

Clinical Study ID

NCT07519772
1045-008
U1111-1324-8720
2025-523005-15-00
  • Ages > 18
  • All Genders

Study Summary

Researchers are looking for new ways to treat 2 types of non-Hodgkin lymphoma (NHL) called follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). FL is a slow-growing type of NHL. DLBCL is a fast-growing type of NHL. NHL is a cancer in the lymphatic system that causes swollen lymph nodes. The lymphatic system is part of the immune system.

In this study, researchers want to learn if MK-1045 can treat FL and DLBCL. MK-1045 is a study treatment that is an immunotherapy, which helps the immune system fight cancer.

The goals of this study are to learn how safe MK-1045 is and if people tolerate it. Researchers also want to see if FL and DLBCL respond (the cancer gets smaller or goes away) to treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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 linesof therapy.

  • Has a histologically confirmed diagnosis of follicular lymphoma (FL) or diffuselarge B-cell lymphoma (DLBCL).

  • DLBCL participants only: has progressed after or is ineligible for transplant andchimeric antigen receptor T (cell) (CAR-T) therapy.

  • Has provided tumor tissue sample (archival or newly obtained, if performed perstandard of care).

  • Has documented retained expression of cluster of differentiation 19 (CD19) in tumortissue obtained by biopsy after disease progression on CD19-targeting therapy, ifexperienced disease progression after prior CD19-targeting therapy.

  • Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy ifhas a history of HIV infection.

  • Has undetectable hepatitis B virus (HBV) viral load and received and will continueto receive HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.

  • Has undetectable hepatitis C virus (HCV) viral load and received HCV antiviraltherapy if has a history of HCV infection.

  • Has radiographically measurable disease per Lugano Response Criteria.

Exclusion

Exclusion Criteria:

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 forGVHD.

  • Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman'sDisease.

  • 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 studyintervention.

  • Has a known additional malignancy that is progressing or required active treatmentwithin 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.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: MK-1045
Phase: 1/2
Study Start date:
May 03, 2026
Estimated Completion Date:
April 01, 2031

Connect with a study center

  • Sanatorio Nuestra Senora del Rosario ( Site 1403)

    Rosario, Santa Fe Province 2001
    Argentina

    Active - Recruiting

  • Beijing Cancer hospital ( Site 1701)

    Beijing, Beijing Municipality 100142
    China

    Active - Recruiting

  • Haddasah Medical Center ( Site 0600)

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center ( Site 0603)

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Sheba Medical Center ( Site 0601)

    Ramat Gan, 5265601
    Israel

    Active - Recruiting

  • Sourasky Medical Center. ( Site 0604)

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • Istituto di Candiolo - IRCCS ( Site 0701)

    Candiolo, Piedmont 10060
    Italy

    Active - Recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 0900)

    Warsaw, Masovian Voivodeship 02-781
    Poland

    Active - Recruiting

  • Pratia Onkologia Katowice ( Site 0902)

    Katowice, Silesian Voivodeship 40-519
    Poland

    Active - Recruiting

  • Hospital Universitari Vall de Hebron ( Site 1102)

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre ( Site 1105)

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Gregorio Maranon ( Site 1101)

    Madrid, 28007
    Spain

    Active - Recruiting

  • The Christie NHS Foundation Trust ( Site 1300)

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

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