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Taking people in BrazilPhase 1/2

MK-1045 for Follicular Lymphoma and Diffuse Large B-Cell Lymphoma

Tests the immunotherapy MK-1045 in adults with two types of non-Hodgkin lymphoma.

Key facts

Who runs it
Merck Sharp & Dohme LLC
Where
Curitiba and São Paulo, BrazilSee the 3 sitesAlso in 15 other countries, 59 sites
Trial code
Registry title
A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)
Status
Recruiting
Phase
Phase 1/2
People taking part
280 people, planned
Started
3 May 2026
Expected to end
1 Apr 2031
Type of study
Interventional, 4 groups
Treatments tested
  • MK-1045
Record updated
10 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with follicular lymphoma or diffuse large B-cell lymphoma that came back or did not respond to at least 2 earlier lines of treatment.

Age
18 Years and older
Sex
All sexes can join.
Disease stage
Follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), confirmed by tissue exam. The disease came back or did not respond to at least 2 earlier systemic treatments. The disease must be measurable on scans (Lugano criteria).
Earlier treatment
At least 2 earlier systemic lines of therapy. People with DLBCL must have progressed after transplant and CAR-T therapy, or cannot have them. CAR-T therapy within 3 months before the first dose is not allowed.
Biomarker or test result
If the disease progressed after earlier CD19-targeting therapy, the tumour must still show CD19 on a biopsy taken after progression. A tumour tissue sample is needed.

Main reasons for not taking part

  • Had a solid organ transplant
  • Active or involved central nervous system lymphoma, or other relevant central nervous system disease
  • Serious heart or brain blood vessel disease in the past
  • Another cancer that is getting worse or needed treatment in the past 2 years
  • Active infection that needs systemic treatment

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Has received a solid organ transplant
  • 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 not recovered from major surgery or has ongoing surgical complications
  • Had or has clinically relevant central nervous system (CNS) diseases
  • Has a history of serious cardiovascular or cerebrovascular diseases
  • Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has a known additional malignancy that is progressing or required active treatment within the past 2 years
  • 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
  • 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
  • The main exclusion criteria include but are not limited to the following:
  • Has known active CNS lymphoma or involvement
  • Has diagnosis of primary mediastinal B-cell lymphoma

Where in Brazil

Also in 15 other countries, 59 sites

  • Hospital Erasto Gaertner (Site 1503)Curitiba, BrazilContact: Study CoordinatorTaking people
  • Hospital das Clinicas FMUSP (Site 1502)São Paulo, BrazilContact: Study CoordinatorTaking people
  • Hospital Paulistano (Site 1504)São Paulo, BrazilContact: Study CoordinatorTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 4 groups in the trial

  • Arm 1: Follicular Lymphoma (FL) MK-1045 Monotherapy Dose OptimizationTreatment being tested

    Participants will receive Dosage A of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation.

    Treatment: MK-1045

  • Arm 2: FL MK-1045 Longer Dosing IntervalTreatment being tested

    Participants will receive Dosage B of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation.

    Treatment: MK-1045

  • Arm 3: FL MK-1045 Subcutaneous AdministrationTreatment being tested

    Participants will receive Dosage C of MK-1045 by subcutaneous (SC) injection for up to approximately 1 year of treatment or until discontinuation.

    Treatment: MK-1045

  • Arm 4: Diffuse Large B-cell Lymphoma (DLBCL) MK-1045 Monotherapy Dose OptimizationTreatment being tested

    Participants will receive Dosage D of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation.

    Treatment: MK-1045

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
MK-1045 for Follicular Lymphoma and Diffuse Large B-Cell LymphomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
10 November 2026