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

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

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.

Conditions4

Interventions1

Related trials

• A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002) — MSD R&D (China) Co., Ltd.
• A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) — Merck Sharp & Dohme LLC
• A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005) — Merck Sharp & Dohme LLC
• A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101) — MSD R&D (China) Co., Ltd.

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