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

Official record

Identifier

NCT07519772

Recruiting locations

countries

United StatesArgentinaAustraliaCanadaChileChinaGermanyIsraelItalyPolandSouth KoreaSpainTurkey (Türkiye)United Kingdom

Interventions studied

MK-1045

Lead sponsor

Merck Sharp & Dohme LLC

Target enrolment

280 participants

Study type

INTERVENTIONAL

Phase

Phase 1/2

Status

Recruiting

First posted

Apr 9, 2026

Last updated on the registry

Sep 25, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Lymphoma