A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)
NCT ID: NCT06189391
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
100 participants
INTERVENTIONAL
2021-03-16
2029-03-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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MK-1045 Fixed Dose
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.
MK-1045
IV infusion
MK-1045 Step-up Dose
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.
MK-1045
IV infusion
Interventions
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MK-1045
IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Has previous or concomitant CNS diseases, including epilepsy, hemorrhagic/ischemic stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disorder, organic cerebellar syndrome, or mental diseases
* Has prior or concomitant malignancies (except cured basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, prostatic intraepithelial neoplasia, and other tumors that have been clinically cured for 5 years as assessed by the investigator)
* Has uncontrolled active infections currently requiring systemic anti-infective therapy within 3 days prior to first dose
* Has active hepatitis B and/or hepatitis C. Participants who are positive for antibodies to hepatitis C virus (HCV). Participants who are hepatitis B surface antigen (HBsAg) positive are not allowed to enroll in the dose-escalation period; however, those who were hepatitis B surface antigen (HBsAg)-positive but hepatitis B Virus deoxyribonucleic acid (HBV DNA)-negative and adherent to entecavir antiviral therapy and who agreed to regular monthly monitoring of HBV DNA are allowed to enroll in the dose-expansion period
* Has a history of immunodeficiency, including testing positive for human immunodeficiency virus (HIV) antibody
* Has a history of serious cardiovascular and cerebrovascular disease, including but not limited to: severe cardiac rhythm or conduction abnormalities; acute coronary syndrome, congestive heart failure, stroke, or other Grade 3 or higher cardiovascular and cerebrovascular events within 6 months prior to the first dose; ≥ Class II cardiac function as per New York Heart Association (NYHA) functional class or LVEF \< 50%; or clinically uncontrollable hypertension
* Has previous or current interstitial lung disease
* Has acute graft-versus-host disease (GVHD) or active chronic GVHD at present
* Has active or history of autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, etc.) that may relapse, or participants who are at risks (e.g., organ transplant requiring immunosuppressive therapy). Participants with the following diseases are allowed to be further screened for enrollment: hypothyroidism managed with hormone replacement therapy only, and skin diseases not requiring systemic treatment (such as vitiligo, psoriasis, or alopecia).
* Has received immunotherapy with known Grade 3 or higher immune-related adverse events (irAEs)
* Has non-hematologic adverse reactions from prior anti-tumor therapy have not recovered to Grade ≤ 1 as assessed by National Cancer Institute NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 (excluding toxicities such as alopecia that are assessed by the investigator to have no safety risk)
18 Years
75 Years
ALL
No
Sponsors
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MSD R&D (China) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp and Dohme LLC
Locations
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Fifth Medical Center of PLA General Hospital ( Site 0005)
Beijing, Beijing Municipality, China
Beijing Cancer hospital ( Site 0001)
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University ( Site 0011)
Xiameng, Fujian, China
Sun Yat-Sen University Cancer Center ( Site 0003)
Guangzhou, Guangdong, China
The Fourth Hospital of Hebei Medical University. ( Site 0004)
Shijiazhuang, Hebei, China
Henan Cancer Hospital ( Site 0009)
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University ( Site 0006)
Zhengzhou, Henan, China
Jiangxi Cancer Hospital ( Site 0007)
Nanchang, Jiangxi, China
The First Hospital Of Jilin University ( Site 0014)
Changchun, Jilin, China
Shandong Cancer Hospital ( Site 0008)
Jinan, Shandong, China
Zhongshan Hospital,Fudan University ( Site 0013)
Shanghai, Shanghai Municipality, China
Shanghai East Hospital ( Site 0002)
Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital. ( Site 0018)
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital ( Site 0010)
Tianjinc, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-1045-001
Identifier Type: OTHER
Identifier Source: secondary_id
CN201-101
Identifier Type: OTHER
Identifier Source: secondary_id
1045-001
Identifier Type: -
Identifier Source: org_study_id