A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

NCT06189391 | Recruiting Phase 1

• 3 other identifiers: 1045-001MK-1045-001CN201-101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 15

Brief Summary

Researchers are looking for new ways to treat people with relapsed or refractory B-Cell Non-Hodgkin Lymphoma (B-NHL). B-cells are a type of white blood cells that make antibodies and help fight infections. Non-Hodgkin Lymphoma is a type of cancer in the lymphatic system causing enlarged lymph nodes and/or organs in belly or chest. Relapsed means a disease or condition comes back after treatment Refractory means a disease does not respond to treatment or stops responding to a treatment. MK-1045, the study medicine, is designed to treat relapsed or refractory B-NHL. MK-1045 is an immunotherapy, which is a treatment that helps the immune system fight cancer. This is the first study in which MK-1045 will be given to people. The goal of this study is to learn about:

• The safety of MK-1045 and how well people tolerate it.
• The highest dose of MK-1045 that is well tolerated.
• How well MK-1045 works to treat relapsed or refractory B-NHL.

Conditions

Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (10)

• Number of Participants who Experience a Dose-limiting Toxicity (DLT)

  DLT are any of the following drug related (DR) investigator-assessed adverse events: Grade 4 neutropenia that does not recover to Grade ≤ 2 after more than 5 days of supportive care including granulocyte colony-stimulating factor (G-CSF), or ≥ Grade 3 febrile neutropenia; Grade 4 platelet (PLT) decreased, or Grade 3 PLT decreased with bleeding; Grade 4 anemia. Grade 4 non-hematologic toxicity; Grade 3 non-hematologic toxicity that does not recover to Grade ≤ 2 within 3 days after best supportive care (excluding simple laboratory abnormalities without clinical significance as assessed by the investigator). Participants with ≥ Grade 3 tumor lysis syndrome who recover to ≤ Grade 2 within 14 days after optimal supportive therapy will be excluded from the definition of DLT. A DLT was also any other toxic reactions requiring permanent discontinuation of the study intervention.

  Up to ~28 Days

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

  An AE is defined as any untoward medical event that occurs after a participant receives the investigational drug, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the study intervention. The number of participants who experience an AE will be reported.

  Up to ~15 months

• Number of Participants who Experience a Serious Adverse Events (SAE)

  An SAE refers to an untoward medical occurrence such as death, life-threatening event, permanent or serious disability or loss of function, need for hospitalization or prolongation of hospitalization after the participant receives the intervention, and congenital abnormalities or birth defects. The number of participants who experience a SAE will be reported.

  Up to ~15 months

• Number of Participants who Experience a Drug-related Adverse Event (DRAE)

  An AE is defined as any untoward medical event that occurs after a participant receives the investigational drug, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the study intervention. A DRAE is defined as an AE definitely related, probably related, or possibly related to the study intervention. The number of participants who have experienced a DRAE will be reported.

  Up to ~15 months

• Number of Participants who Experience an AE of Grade 3 or higher

  An AE is defined as any untoward medical event that occurs after a participant receives the study intervention, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the study intervention. AEs are graded on a scale from 1-5 with 1=Mild, 2=Moderate, 3=Severe or medically significant but not immediately life-threatening, 4= Life threatening consequences, and 5=Death due to AE. The number of participants who experience an AE of grade 3 or above will be presented.

  Up to ~15 months

• Number of Participants who Experience an AE for Each Severity Grade from 1-5

  An AE is defined as any untoward medical event that occurs after a participant receives the study intervention, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the study intervention. AEs are graded on a scale from 1-5 with 1=Mild, 2=Moderate, 3=Severe or medically significant but not immediately life-threatening, 4= Life threatening consequences, and 5=Death due to AE. The number of participants who experience an AE in each category of AEs from 1-5 will be presented.

  Up to ~15 months

• Number of Participants who Experience a SAE or Serious Drug-related AE

  An SAE refers to an untoward medical occurrence such as death, life-threatening event, permanent or serious disability or loss of function, need for hospitalization or prolongation of hospitalization after the participant receives the study intervention, and congenital abnormalities or birth defects. A drug related SAE is defined as an SAE definitely related, probably related, or possibly related to the study intervention. The number of participants who experience a SAE or a serious drug-related AE will be reported.

  Up to ~15 months

• Number of Participants who Experience a Dose Modification Due to an AE or DRAE

  An AE is defined as any untoward medical event that occurs after a participant receives the study intervention, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the study intervention. A drug related AE includes AEs definitely related, probably related, and possibly related to the study intervention. The number of participants who experience a dose modification due to an AE or DRAE will be presented.

  Up to ~15 months

• Number of Participants who Withdraw from the Study due to an AE or DRAE

  An AE is defined as any untoward medical event that occurs after a participant receives the study intervention, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the study intervention. A drug related AE includes AEs definitely related, probably related, and possibly related to the study intervention. The number of participants who discontinue the study due to an AE will be presented.

  Up to ~15 months

• Number of Participants who Died due to an AE or DRAE

  An AE is defined as any untoward medical event that occurs after a participant receives the study intervention, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the study intervention. A drug related AE includes AEs definitely related, probably related, and possibly related to the study intervention. The number of participants who died due to an AE or DRAE will be presented.

  Up to ~15 months

Secondary Outcomes (25)

• Mean Change in Serum MK-1045 Concentration After Administration

  Baseline and up to 12 months

• Area Under the Concentration-time Curve (AUC) of MK-1045

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

• Area Under the Concentration-time Curve from Time 0 to 168 Hours Post Dose (AUC0-168) of MK-1045

  Pre-dose and at designated time points post-dose up to 168 hours

• Area Under the Concentration-time Curve from Time 0 to Last Quantifiable Concentration Post Dose (AUC0-last) of MK-1045

  Pre-dose and at designated time points post-dose up to 168 hours

• Maximum Concentration (Cmax) of MK-1045

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

Study Arms (2)

MK-1045 Fixed Dose

EXPERIMENTAL

Participants will receive MK-1045 via intravenous (IV) infusion on Day 1 of each week for 3 consecutive weeks followed by one week off of each four-week cycle for up to 12 months until discontinuation or death.

Drug: MK-1045

MK-1045 Step-up Dose

EXPERIMENTAL

Participants will receive MK-1045 via an IV infusion in a step-up dose with priming once a week (Q1W) for a 3-week cycle for up to 12 months until discontinuation or death.

Drug: MK-1045

Interventions

MK-1045 DRUG

IV infusion

Also known as: CN201

MK-1045 Fixed Dose; MK-1045 Step-up Dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Has relapsed or refractory B-cell Non-Hodgkin's lymphoma (B-NHL) with disease history meeting the following World Health Organization (WHO) diagnostic subtypes of B-NHL that are CD19-positive in pathologic Immunohistochemistry test: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) (Grade I to III), marginal zone lymphoma, lymphoplasmacytic lymphoma, mantle cell lymphoma, small lymphocytic lymphoma, and transformed large B-cell lymphoma (During the dose-escalation phase, participants other than those treated with Chimeric antigen receptor T-cell (CAR-T) who cannot provide proof of pathologic immunohistochemistry CD19 positivity but have previous proof of CD20 positivity may be considered for enrollment after discussion with the sponsor)
• Relapse is defined as the occurrence of progressive disease (PD) after complete response (CR) or partial response (PR) has been achieved after adequate treatment. Note: For DLBCL participants, relapse must occur after participants undergoing at least two lines of therapy; for other participants, they must undergo at least one line of therapy.
• Refractory is defined as a situation that there is no standard of care available or that it is not applicable to use standard of care at this stage, including: Participants who are unresponsive to standard of care (e.g., monotherapy or combination therapy containing anti-CD20 monoclonal antibody) and whose best response to standard therapy is PD or stable disease (SD); Participants who are not eligible for autologous hematopoietic stem cell transplantation (ASCT) and have relapsed PD after receiving ASCT; Participants who have failed on chimeric antigen receptor T cell (CAR-T) immunotherapy, but the first dose of the study intervention must be at least 3 months after discontinuation of CAR-T therapy, and CD19 positive expression is still present in tumor tissue.
• Has at least one evaluable tumor lesion per the Lugano 2014 criteria, i.e., a lymph node lesion \> 15 mm in long diameter or an extranodal lesion \> 10 mm in long diameter according to computed tomography (CT) cross-sectional imaging or magnetic resonance imaging (MRI)
• Has an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2 and an estimated survival time of more than 3 months
• Has essentially normal: bone marrow function; coagulation function; liver function; kidney function; lung function; and heart function
• Has been treated with anti-CD3/CD19 bispecific antibody (BsAb) prior to first dose of study intervention
• Has received chemotherapy, endocrine therapy, radiotherapy (palliative radiotherapy 2 weeks prior to the first administration of the investigational drug), or biologic therapy, and small molecule targeted agents within 2 weeks prior to the first administration of the investigational drug or within 5 half-lives of the drug, whichever is shorter
• Has received anti-CD20 antibody or anti-CD19 antibody within 4 weeks prior to first use of the investigational drug
• Has received anti-tumor immunotherapy or other unlisted clinical study intervention within 4 weeks prior to the first dose of study intervention, or within 5 half-lives of the drug, whichever is shorter
• Has undergone any major organ surgery (excluding aspiration biopsy) or significant trauma within 4 weeks prior to the first dose of study intervention or those requiring elective surgeries during the study
• Has received systemic corticosteroids (prednisone \>10 mg/day or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of the study intervention, excluding the following agents: topical, ocular, intra-articular, intranasal, and inhaled corticosteroids, and short-term, prophylactic use of corticosteroids (e.g. to prevent radio contrast agent induced allergic reactions)
• Has used immunomodulatory agents, including but not limited to thymosin, interleukin-2 (IL-2), interferon (IFN) and anti-tumor Chinese patent drugs or Chinese herbal medicines within 14 days prior to the first dose of study intervention
• Has had a live attenuated vaccines within 4 weeks prior to the first dose of study intervention
• Has a central nervous system (CNS) infiltration

Sponsors & Collaborators

• MSD R&D (China) Co., Ltd.: lead

Study Sites (15)

Fifth Medical Center of PLA General Hospital ( Site 0005)

Beijing, Beijing Municipality, 100071, China

RECRUITING

Beijing Cancer hospital ( Site 0001)

Beijing, Beijing Municipality, 100142, China

RECRUITING

The First Affiliated Hospital of Xiamen University ( Site 0011)

Xiameng, Fujian, 361000, China

RECRUITING

Sun Yat-Sen University Cancer Center ( Site 0003)

Guangzhou, Guangdong, 510060, China

RECRUITING

The Fourth Hospital of Hebei Medical University. ( Site 0004)

Shijiazhuang, Hebei, 050035, China

RECRUITING

Henan Cancer Hospital ( Site 0009)

Zhengzhou, Henan, 450000, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University ( Site 0006)

Zhengzhou, Henan, 451161, China

RECRUITING

Jiangxi Cancer Hospital ( Site 0007)

Nanchang, Jiangxi, 330029, China

RECRUITING

The First Hospital Of Jilin University ( Site 0014)

Changchun, Jilin, 130021, China

RECRUITING

Shandong Cancer Hospital ( Site 0008)

Jinan, Shandong, 250117, China

ACTIVE NOT RECRUITING

Fudan University Shanghai Cancer Center ( Site 0012)

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Zhongshan Hospital,Fudan University ( Site 0013)

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Shanghai East Hospital ( Site 0002)

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Sichuan Cancer Hospital. ( Site 0018)

Chengdu, Sichuan, 610041, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital ( Site 0010)

Tianjinc, Tianjin Municipality, 300060, China

ACTIVE NOT RECRUITING

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Recurrence; Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Medical Director

  Merck Sharp and 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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: January 3, 2024
• Study Start: March 16, 2021
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): March 30, 2029
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (15)