A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
200 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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