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

RECRUITINGPHASE1

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

An Open-Label, Dose Escalation Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of MK-1045 (CN201) in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

NCT06189391•MSD R&D (China) Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•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
+12 more criteria

Exclusion Criteria

•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

Locations (15)

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

Key Dates

Start Date

March 16, 2021

Primary Completion Date

September 30, 2028

Completion Date

March 30, 2029

Last Updated

March 19, 2026

Enrollment

100

ESTIMATED participants

Conditions

Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Interventions

MK-1045

DRUG

Contacts

Toll Free Number

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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