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NCT07519772PHASE1, PHASE2Recruiting

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

Merck Sharp & Dohme LLC

Start Date

5/3/2026

Completion Date

4/1/2031

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

Age Range: 18 years to No maximum

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 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 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 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.

Interventions

BIOLOGICAL

MK-1045

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Conditions

Lymphoma, Non-HodgkinLymphoma, FollicularLymphoma, Large B-Cell, Diffuse

Locations

Colorado Blood Cancer Institute ( Site 7000)

Denver, Colorado 80218

United States

SCRI Oncology Partners ( Site 0100)

Nashville, Tennessee 37203

United States

Instituto Alexander Fleming ( Site 1404)

Ciudad Autonoma de Buenos Aires, Buenos Aires C1426ANZ

Argentina

Sanatorio Nuestra Senora del Rosario ( Site 1403)

Rosario, Santa Fe Province 2001

Argentina

Beijing Cancer hospital ( Site 1701)

Beijing, Beijing Municipality 100142

China

Shaare Zedek Medical Center ( Site 0603)

Jerusalem, 9103102

Israel

Haddasah Medical Center ( Site 0600)

Jerusalem, 9112001

Israel

Sheba Medical Center ( Site 0601)

Ramat Gan, 5265601

Israel

Sourasky Medical Center. ( Site 0604)

Tel Aviv, 6423906

Israel

INOC - Istituto Nazionale Oncologico Candiolo ( Site 0701)

Candiolo, Piedmont 10060

Italy

Pratia MCM Krakow ( Site 0903)

Krakow, Lesser Poland Voivodeship 30-727

Poland

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

Warsaw, Masovian Voivodeship 02-781

Poland

Pratia Onkologia Katowice ( Site 0902)

Katowice, Silesian Voivodeship 40-519

Poland

Institut Català d'Oncologia (ICO) - Badalona ( Site 1103)

Badalona, Barcelona 08916

Spain

Hospital Virgen de la Victoria ( Site 1104)

Málaga, Malaga 29010

Spain

Hospital Universitari Vall de Hebron ( Site 1102)

Barcelona, 08035

Spain

Hospital Universitario Gregorio Maranon ( Site 1101)

Madrid, 28007

Spain

Hospital Universitario 12 de Octubre ( Site 1105)

Madrid, 28041

Spain

Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1000)

Ankara, 06230

Turkey (Türkiye)

Koç Üniversitesi Hastanesi ( Site 1001)

Istanbul, 34010

Turkey (Türkiye)

Derriford Hospital ( Site 1304)

Plymouth, Devon Pl6 8DH

United Kingdom

The Christie NHS Foundation Trust ( Site 1300)

Manchester, M20 4BX

United Kingdom