A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)
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
- Lymphoma, Non-Hodgkin
- Lymphoma, Follicular
- Lymphoma, Large B-Cell, Diffuse
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Merck Sharp & Dohme LLC
- Enrolment target
- 280
- Started
- 3 May 2026
- Main results due
- 1 July 2030
- Study sites
- 41
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(41)
Colorado Blood Cancer Institute ( Site 7000)
Denver, Colorado, United States
Recruiting
SCRI Oncology Partners ( Site 0100)
Nashville, Tennessee, United States
Recruiting
Instituto Alexander Fleming ( Site 1404)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Recruiting
Hospital Universitario Austral ( Site 1402)
Pilar, Buenos Aires, Argentina
Recruiting
Sanatorio Nuestra Senora del Rosario ( Site 1403)
Rosario, Santa Fe Province, Argentina
Recruiting
Hospital Aleman ( Site 1400)
CABA, Argentina
Recruiting
Townsville University Hospital ( Site 0204)
Townsville, Queensland, Australia
Recruiting
Box Hill Hospital ( Site 0202)
Box Hill, Victoria, Australia
Recruiting
Princess Margaret Cancer Centre ( Site 0301)
Toronto, Ontario, Canada
Recruiting
Clínica Alemana de Santiago ( Site 1608)
Santiago, Region M. de Santiago, Chile
Recruiting
Beijing Cancer hospital ( Site 1701)
Beijing, Beijing Municipality, China
Recruiting
Sun Yat-Sen University Cancer Center ( Site 1712)
Guangzhou, Guangdong, China
Recruiting
Fudan University Shanghai Cancer Center ( Site 1711)
Shanghai, Shanghai Municipality, China
Recruiting
UKGM Gießen/Marburg ( Site 0505)
Giessen, Hesse, Germany
Recruiting
Carmel Hospital ( Site 0602)
Haifa, Israel
Recruiting
Shaare Zedek Medical Center ( Site 0603)
Jerusalem, Israel
Recruiting
Haddasah Medical Center ( Site 0600)
Jerusalem, Israel
Recruiting
Sheba Medical Center ( Site 0601)
Ramat Gan, Israel
Recruiting
Sourasky Medical Center. ( Site 0604)
Tel Aviv, Israel
Recruiting
Istituto Nazionale Tumori IRCCS Fondazione Pascale-SC Ematologia Oncologica ( Site 0700)
Campania, Napoli, Italy
Recruiting
INOC - Istituto Nazionale Oncologico Candiolo ( Site 0701)
Candiolo, Piedmont, Italy
Recruiting
Istituto Europeo di Oncologia IRCCS ( Site 0702)
Milan, Italy
Recruiting
Fondazione Policlinico Universitario Agostino Gemelli ( Site 0705)
Roma, Italy
Recruiting
Pratia MCM Krakow ( Site 0903)
Krakow, Lesser Poland Voivodeship, Poland
Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 0900)
Warsaw, Masovian Voivodeship, Poland
Recruiting
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0901)
Gliwice, Silesian Voivodeship, Poland
Recruiting
Pratia Onkologia Katowice ( Site 0902)
Katowice, Silesian Voivodeship, Poland
Recruiting
Seoul National University Hospital ( Site 0800)
Seoul, South Korea
Recruiting
The Catholic University of Korea, Yeouido St. Mary's Hospital ( Site 0801)
Seoul, South Korea
Recruiting
Institut Català d'Oncologia (ICO) - Badalona ( Site 1103)
Badalona, Barcelona, Spain
Recruiting
Hospital Virgen de la Victoria ( Site 1104)
Málaga, Malaga, Spain
Recruiting
Hospital Universitari Vall de Hebron ( Site 1102)
Barcelona, Spain
Recruiting
Hospital Universitario Gregorio Maranon ( Site 1101)
Madrid, Spain
Recruiting
Hospital Universitario 12 de Octubre ( Site 1105)
Madrid, Spain
Recruiting
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1000)
Ankara, Turkey (Türkiye)
Recruiting
Antalya Egitim ve Arastirma Hastanesi ( Site 1003)
Antalya, Turkey (Türkiye)
Recruiting
Koç Üniversitesi Hastanesi ( Site 1001)
Istanbul, Turkey (Türkiye)
Recruiting
Medipol Mega Universite Hastanesi ( Site 1002)
Istanbul, Turkey (Türkiye)
Recruiting
Samsun Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi ( Site 1005)
Samsun, Turkey (Türkiye)
Recruiting
Derriford Hospital ( Site 1304)
Plymouth, Devon, United Kingdom
Recruiting
The Christie NHS Foundation Trust ( Site 1300)
Manchester, United Kingdom
Recruiting
Showing 41 of 41 sites. 41 of the 41 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07519772. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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