NCT07519772 A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)
| NCT ID | NCT07519772 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Merck Sharp & Dohme LLC |
| Condition | Lymphoma, Non-Hodgkin |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-05-03 |
| Primary Completion | 2030-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 200 participants in total. It began in 2026-05-03 with a primary completion date of 2030-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Medical Director
STUDY DIRECTOR
Merck Sharp & Dohme LLC
Frequently Asked Questions
Who can join the NCT07519772 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lymphoma, Non-Hodgkin. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07519772 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07519772 currently recruiting?
Yes, NCT07519772 is actively recruiting participants. Contact the research team at Trialsites@msd.com for enrollment information.
Where is the NCT07519772 trial being conducted?
This trial is being conducted at Denver, United States, Nashville, United States, Ciudad Autonoma de Buenos Aires, Argentina, Rosario, Argentina and 11 additional locations.
Who is sponsoring the NCT07519772 clinical trial?
NCT07519772 is sponsored by Merck Sharp & Dohme LLC. The principal investigator is Medical Director at Merck Sharp & Dohme LLC. The trial plans to enroll 200 participants.