MK-1045 for Follicular Lymphoma and Diffuse Large B-Cell Lymphoma
Tests the immunotherapy MK-1045 in adults with two types of non-Hodgkin lymphoma.
Plain-language title generated from the registry record
Registry title: A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)
Key facts
- Where
- Cracow, Gliwice, Katowice, and Warsaw, PolandSee the 4 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with follicular lymphoma or diffuse large B-cell lymphoma that came back or did not respond to at least 2 earlier lines of treatment.
- Age
- 18 Years and older
- Sex
- All sexes can join.
- Disease stage
- Follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), confirmed by tissue exam. The disease came back or did not respond to at least 2 earlier systemic treatments. The disease must be measurable on scans (Lugano criteria).
- Earlier treatment
- At least 2 earlier systemic lines of therapy. People with DLBCL must have progressed after transplant and CAR-T therapy, or cannot have them. CAR-T therapy within 3 months before the first dose is not allowed.
- Biomarker or test result
- If the disease progressed after earlier CD19-targeting therapy, the tumour must still show CD19 on a biopsy taken after progression. A tumour tissue sample is needed.
Main reasons for not taking part
- Had a solid organ transplant
- Active or involved central nervous system lymphoma, or other relevant central nervous system disease
- Serious heart or brain blood vessel disease in the past
- Another cancer that is getting worse or needed treatment in the past 2 years
- Active infection that needs systemic treatment
Read by machine on 11 November 2026.
Where in Poland
- Pratia S.A.Cracow, PolandTaking people
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut BadawczyGliwice, PolandTaking people
- Pratia Hematologia Sp. Z o. oKatowice, PolandTaking people
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyWarsaw, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT07519772EU 2025-523005-15-00
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Has received a solid organ transplant; 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 not recovered from major surgery or has ongoing surgical complications; Had or has clinically relevant central nervous system (CNS) diseases; Has a history of serious cardiovascular or cerebrovascular diseases; Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease; Has a known additional malignancy that is progressing or required active treatment within the past 2 years; 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; 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; The main exclusion criteria include but are not limited to the following:; Has known active CNS lymphoma or involvement; Has diagnosis of primary mediastinal B-cell lymphoma.