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

NCT07519772 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: 1045-008U1111-1324-87202025-523005-15-00
• Study Type: interventional
• Target: 200
• Locations: 9 countries
• Sites: 22

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.

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse

Outcome Measures

Primary Outcomes (5)

• Number of Participants Who Experience an Adverse Event (AE)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

  Up to approximately 44 months

• Number of Participants Who Discontinue Study Treatment Due to an AE

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

  Up to approximately 12 months

• Arms 2 and 3: Number of Participants Who Experience Dose Limiting Toxicity (DLT)

  DLT will be defined as any drug-related AE observed during the DLT evaluation period (up to 28 days) that results in a change to a given dose or a delay in initiating the next treatment.

  Up to approximately 28 Days

• Arms 1 and 4: Objective Response Rate (ORR) per Lugano Response Criteria as assessed by Blinded Independent Central review (BICR)

  ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and will be evaluated using computed tomography (CT) and positron emission tomography (PET)-CT. Response will be assessed based on the International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose \[FDG\] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). In Arms 1 and 4, the percentage of participants who experience CR or PR as assessed by BICR will be presented.

  Up to approximately 44 months

• Arm 2: ORR per Lugano Response Criteria as assessed by Investigator

  ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and will be evaluated using computed tomography (CT) and positron emission tomography (PET)-CT. Response will be assessed based on the International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose \[FDG\] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). In Arm 2, the percentage of participants who experience CR or PR as assessed by the Investigator will be presented.

  Up to approximately 44 months

Secondary Outcomes (8)

• Arms 1 and 4: Duration of Response (DOR) per Lugano Response Criteria as assessed by BICR

  Up to approximately 44 months

• Arms 2 and 3: DOR per Lugano Response Criteria as assessed by Investigator

  Up to approximately 44 months

• Area Under the Concentration-time Curve Measured at Steady State (AUCss) of MK-1045

  Pre-dose and at designated time points post-dose up to 12 months

• Trough Concentration (Ctrough) of MK-1045

  Pre-dose and at designated time points post-dose up to 12 months

• Maximum Serum Concentration (Cmax) of MK-1045

  Pre-dose and at designated time points post-dose up to 12 months

Study Arms (4)

Arm 1: Follicular Lymphoma (FL) MK-1045 Monotherapy Dose Optimization

EXPERIMENTAL

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

Biological: MK-1045

Arm 2: FL MK-1045 Longer Dosing Interval

EXPERIMENTAL

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

Biological: MK-1045

Arm 3: FL MK-1045 Subcutaneous Administration

EXPERIMENTAL

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

Biological: MK-1045

Arm 4: Diffuse Large B-cell Lymphoma (DLBCL) MK-1045 Monotherapy Dose Optimization

EXPERIMENTAL

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

Biological: MK-1045

Interventions

MK-1045 BIOLOGICAL

Intravenous (IV) Infusion or Subcutaneous (SC) injection

Also known as: CN-201

Arm 1: Follicular Lymphoma (FL) MK-1045 Monotherapy Dose Optimization; Arm 2: FL MK-1045 Longer Dosing Interval; Arm 3: FL MK-1045 Subcutaneous Administration; Arm 4: Diffuse Large B-cell Lymphoma (DLBCL) MK-1045 Monotherapy Dose Optimization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (22)

Colorado Blood Cancer Institute ( Site 7000)

Denver, Colorado, 80218, United States

RECRUITING

SCRI Oncology Partners ( Site 0100)

Nashville, Tennessee, 37203, United States

RECRUITING

Instituto Alexander Fleming ( Site 1404)

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

RECRUITING

Sanatorio Nuestra Senora del Rosario ( Site 1403)

Rosario, Santa Fe Province, 2001, Argentina

RECRUITING

Beijing Cancer hospital ( Site 1701)

Beijing, Beijing Municipality, 100142, China

RECRUITING

Shaare Zedek Medical Center ( Site 0603)

Jerusalem, 9103102, Israel

RECRUITING

Haddasah Medical Center ( Site 0600)

Jerusalem, 9112001, Israel

RECRUITING

Sheba Medical Center ( Site 0601)

Ramat Gan, 5265601, Israel

RECRUITING

Sourasky Medical Center. ( Site 0604)

Tel Aviv, 6423906, Israel

RECRUITING

INOC - Istituto Nazionale Oncologico Candiolo ( Site 0701)

Candiolo, Piedmont, 10060, Italy

RECRUITING

Pratia MCM Krakow ( Site 0903)

Krakow, Lesser Poland Voivodeship, 30-727, Poland

RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 0900)

Warsaw, Masovian Voivodeship, 02-781, Poland

RECRUITING

Pratia Onkologia Katowice ( Site 0902)

Katowice, Silesian Voivodeship, 40-519, Poland

RECRUITING

Institut Català d'Oncologia (ICO) - Badalona ( Site 1103)

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital Virgen de la Victoria ( Site 1104)

Málaga, Malaga, 29010, Spain

RECRUITING

Hospital Universitari Vall de Hebron ( Site 1102)

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario Gregorio Maranon ( Site 1101)

Madrid, 28007, Spain

RECRUITING

Hospital Universitario 12 de Octubre ( Site 1105)

Madrid, 28041, Spain

RECRUITING

Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1000)

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Koç Üniversitesi Hastanesi ( Site 1001)

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

Derriford Hospital ( Site 1304)

Plymouth, Devon, Pl6 8DH, United Kingdom

RECRUITING

The Christie NHS Foundation Trust ( Site 1300)

Manchester, M20 4BX, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 9, 2026
• Study Start: May 3, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): April 1, 2031
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (2); TU (2); PL (3); ES (5); IL (4); AR (2); IT (1); CN (1); GB (2)