Clinical trial · Interventional
A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Follicular | Follicular Lymphoma | ALIAS | 0.90 |
| Lymphoma, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MK-1045 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm 1: Follicular Lymphoma (FL) MK-1045 Monotherapy Dose Optimization
- description
- Participants will receive Dosage A of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation.
- interventionNames
- Biological: MK-1045
- type
- EXPERIMENTAL
- label
- Arm 2: FL MK-1045 Longer Dosing Interval
- description
- Participants will receive Dosage B of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation.
- interventionNames
- Biological: MK-1045
- type
- EXPERIMENTAL
- label
- Arm 3: FL MK-1045 Subcutaneous Administration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available