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

Recruiting now · Phase 1/Phase 2

Conditions studied: Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse

In brief

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.

Key facts

Study ID

NCT07519772

Run by

Merck Sharp & Dohme LLC

People needed

280

Starts

2026-05-03

Expected to finish

2031-04-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Colorado Blood Cancer Institute ( Site 7000) — Denver, Colorado, United States (enrolling)
• SCRI Oncology Partners ( Site 0100) — Nashville, Tennessee, United States (enrolling)
• Instituto Alexander Fleming ( Site 1404) — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina (enrolling)
• Sanatorio Nuestra Senora del Rosario ( Site 1403) — Rosario, Santa Fe Province, Argentina (enrolling)
• Townsville University Hospital ( Site 0204) — Townsville, Queensland, Australia (enrolling)
• Beijing Cancer hospital ( Site 1701) — Beijing, Beijing Municipality, China (enrolling)
• Carmel Hospital ( Site 0602) — Haifa, Israel (enrolling)
• Shaare Zedek Medical Center ( Site 0603) — Jerusalem, Israel (enrolling)
• Haddasah Medical Center ( Site 0600) — Jerusalem, Israel (enrolling)
• Sheba Medical Center ( Site 0601) — Ramat Gan, Israel (enrolling)
• Sourasky Medical Center. ( Site 0604) — Tel Aviv, Israel (enrolling)
• Istituto Nazionale Tumori IRCCS Fondazione Pascale-SC Ematologia Oncologica ( Site 0700) — Campania, Napoli, Italy (enrolling)
• INOC - Istituto Nazionale Oncologico Candiolo ( Site 0701) — Candiolo, Piedmont, Italy (enrolling)
• Istituto Europeo di Oncologia IRCCS ( Site 0702) — Milan, Italy (enrolling)
• Fondazione Policlinico Universitario Agostino Gemelli ( Site 0705) — Roma, Italy (enrolling)
• Pratia MCM Krakow ( Site 0903) — Krakow, Lesser Poland Voivodeship, Poland (enrolling)
• Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 0900) — Warsaw, Masovian Voivodeship, Poland (enrolling)
• Pratia Onkologia Katowice ( Site 0902) — Katowice, Silesian Voivodeship, Poland (enrolling)
• The Catholic University of Korea, Yeouido St. Mary's Hospital ( Site 0801) — Seoul, South Korea (enrolling)
• Institut Català d'Oncologia (ICO) - Badalona ( Site 1103) — Badalona, Barcelona, Spain (enrolling)
• Hospital Virgen de la Victoria ( Site 1104) — Málaga, Malaga, Spain (enrolling)
• Hospital Universitari Vall de Hebron ( Site 1102) — Barcelona, Spain (enrolling)
• Hospital Universitario Gregorio Maranon ( Site 1101) — Madrid, Spain (enrolling)
• Hospital Universitario 12 de Octubre ( Site 1105) — Madrid, Spain (enrolling)
• Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1000) — Ankara, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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