AzTrials
AzTrials

Relapsed or Refractory B-Cell Non-Hodgkin LymphomaPhase 1NCT06189391

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

A Phase 1 study testing MK-1045 in people with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, run by MSD R&D (China) Co., Ltd. at 15 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
MK-1045
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
15 sitesChina
Study dates
16 Mar 2021to 30 Mar 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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, excluding 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 communication 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

Who cannot join

  • Has any other non-Hodgkin lymphoma (NHL) not listed in inclusion criteria
  • 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
Show all 21Show fewer
  • 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, 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)

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

15 sites in 1 country

China15 sites, 13 recruiting

  • Fifth Medical Center of PLA General Hospital ( Site 0005)

    Beijing, Beijing Municipality, 100071

    Study Coordinator, +861066947114

    Recruiting

  • Beijing Cancer hospital ( Site 0001)

    Beijing, Beijing Municipality, 100142

    Study Coordinator, 01088196116

    Recruiting

  • The First Hospital Of Jilin University ( Site 0014)

    Changchun, Jilin, 130021

    Study Coordinator, 8613039046656

    Recruiting

  • Sichuan Cancer Hospital. ( Site 0018)

    Chengdu, Sichuan, 610041

    Study Coordinator, 028-85420305

    Recruiting

  • Sun Yat-Sen University Cancer Center ( Site 0003)

    Guangzhou, Guangdong, 510060

    Study Coordinator, 020 87343349

    Recruiting

  • Shandong Cancer Hospital ( Site 0008)

    Jinan, Shandong, 250117

    Active, not recruiting

  • Jiangxi Cancer Hospital ( Site 0007)

    Nanchang, Jiangxi, 330029

    Study Coordinator, 079188317256

    Recruiting

  • Fudan University Shanghai Cancer Center ( Site 0012)

    Shanghai, Shanghai Municipality, 200030

    Study Coordinator, +86216417559082107

    Recruiting

  • Zhongshan Hospital,Fudan University ( Site 0013)

    Shanghai, Shanghai Municipality, 200032

    Study Coordinator, 021-64041990-692225

    Recruiting

  • Shanghai East Hospital ( Site 0002)

    Shanghai, Shanghai Municipality, 200120

    Study Coordinator, 02138804518

    Recruiting

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

    Shijiazhuang, Hebei, 050035

    Study Coordinator, 031186296322

    Recruiting

  • Tianjin Medical University Cancer Institute and Hospital ( Site 0010)

    Tianjinc, Tianjin Municipality, 300060

    Active, not recruiting

  • The First Affiliated Hospital of Xiamen University ( Site 0011)

    Xiameng, Fujian, 361000

    Study Coordinator, 0592 2139866

    Recruiting

  • Henan Cancer Hospital ( Site 0009)

    Zhengzhou, Henan, 450000

    Study Coordinator, 400-0371-818

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University ( Site 0006)

    Zhengzhou, Henan, 451161

    Study Coordinator, 0371-67966266

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Read more

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.
Being tested
MK-1045
Medical subject headings
Recurrence, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-1045Drug

    Also called CN201

    IV infusion

Study groups in NCT06189391
Study groupRoleWhat they receive
MK-1045 Fixed DoseExperimentalParticipants 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.
Receives: Drug: MK-1045
MK-1045 Step-up DoseExperimentalParticipants 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.
Receives: Drug: MK-1045

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to ~28 Days

  2. 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.

    Measured: Up to ~15 months

  3. 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.

    Measured: Up to ~15 months

  4. 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.

    Measured: Up to ~15 months

  5. 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.

    Measured: Up to ~15 months

  6. 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.

    Measured: Up to ~15 months

  7. 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.

    Measured: Up to ~15 months

  8. 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.

    Measured: Up to ~15 months

  9. 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.

    Measured: Up to ~15 months

  10. 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.

    Measured: Up to ~15 months

Secondary outcomes (25)

  1. Mean Change in Serum MK-1045 Concentration After Administration

    Blood samples will be collected to determine the mean change from baseline in serum concentration of MK-1045.

    Measured: Baseline and up to 12 months

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

    Blood samples will be collected to determine the AUC of MK-1045 in plasma.

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

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

    Blood samples will be collected to determine the AUC0-168 of MK-1045 in plasma.

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

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

    Blood samples will be collected to determine the AUC0-last of MK-1045 in plasma.

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

  5. Maximum Concentration (Cmax) of MK-1045

    Blood samples will be collected to determine the Cmax of MK-1045 in plasma.

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

  6. Time to Maximum Concentration (Tmax) of MK-1045

    Blood samples will be collected to determine the Tmax of MK-1045 in plasma.

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

  7. Terminal Elimination Half-life (T1/2) of MK-1045

    Blood samples will be collected to determine the t1/2 of MK-1045 in plasma.

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

  8. Clearance (CL) of MK-1045

    Blood samples will be collected to determine the CL of MK-1045 in plasma.

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

  9. Concentration at the End of Dosing Interval (Ctrough) of MK-1045

    Blood samples will be collected to determine the Ctrough of MK-1045 in plasma.

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

  10. Area Under the Concentration-time Curve from Time 0 to the Dosing Interval (168 Hours) at Steady State (AUC0-tau) of MK-1045

    Blood samples will be collected to determine the AUC0-tau of MK-1045 in plasma.

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

  11. Accumulatio Ratio Based on Cmax (RAC-Cmax) of MK-1045

    Blood samples will be collected to determine the RAC_Cmax of MK-1045 in plasma.

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

  12. Accumulation Ratio Based on AUC0-tau (RAC_AUC0-tau) of MK-1045

    Blood samples will be collected to determine the RAC-AUC0-tau of MK-1045 in plasma.

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

  13. Steady State Clearance (CLss) of MK-1045

    Blood samples will be collected to determine the CLss of MK-1045 in plasma.

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

  14. Steady State Apparent Volume of Distribution (Vss) of MK-1045

    Blood samples will be collected to determine the Vss of MK-1045.

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

  15. Mean Number of B Cells in Peripheral Blood After Administration of MK-1045

    Blood samples will be collected to determine the mean number of B cells in peripheral blood after treatment with MK-1045.

    Measured: Baseline and up to 12 months

  16. Mean Number of T cells in Peripheral Blood After Administration of MK-1045

    Blood samples will be collected to determine the mean number of T cells in peripheral blood after treatment with MK-1045.

    Measured: Baseline and up to 12 months

  17. Mean Level of T Cell Activation After Administration with MK-1045

    Blood samples will be collected to determine the mean T cell activation after treatment with MK-1045.

    Measured: Baseline and up to 12 months

  18. Mean Level of T Cell Proliferation After Administration of MK-1045

    Blood samples will be collected to determine the mean level of T cell proliferation after treatment with MK-1045.

    Measured: Baseline and up to 12 months

  19. Mean Level of Cytokines in Peripheral Blood After Administration of MK-1045

    Blood samples will be collected to determine the mean level of cytokines after treatment with MK-1045.

    Measured: Baseline up to 12 months

  20. Percentage of Participants who Develop Anti-drug Antibodies (ADA) to MK-1045

    Blood samples will be collected to determine the percentage of participants with ADAs to MK-1045 after treatment with MK-1045.

    Measured: Baseline and up to 15 months

  21. Objective Response Rate (ORR)

    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 ≤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). The percentage of participants who experience CR or PR will be presented.

    Measured: Up to 15 months

  22. Duration of Response (DOR)

    For participants who demonstrate a CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. Participants will be evaluated using CT and metabolic imaging (FDG-PET). CR is complete metabolic (no/minimal 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). DOR will be presented among participants who demonstrated CR or PR.

    Measured: Up to ~15 months

  23. Complete Response Rate (CRR)

    CRR is defined as the percentage of the participants who had complete response (CR) 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 ≤5 cm in longest transverse diameter of a lesion) and no new lesions. The percentage of participants who experience a CR will be presented.

    Measured: Up to ~15 months

  24. Duration of Complete Response (DCR)

    For participants who demonstrate a CR, DCR is defined as the time from the first documented evidence of CR until disease progression or death due to any cause, whichever occurs first. Participants will be evaluated using CT and metabolic imaging (FDG-PET). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. DCR for participants with CR will be presented.

    Measured: Up to ~15 months

  25. Progression Free Survival (PFS)

    PFS is defined as the time from first dose to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PD per Lugano criteria is defined as new or increased adenopathy, splenic volume increase, new or larger non-measured lesions, recurrent previously resolved lesions, new extranodal lesion >1 cm in any axis, a new node >1.5 cm in any axis. PFS will be presented.

    Measured: Up to ~15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2024
  2. Study start16 Mar 2021
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06189391
Sponsor's protocol ID
1045-001
Other IDs
MK-1045-001, CN201-101
Status last verified
Oct 2026
First submitted
30 Aug 2023
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-1045 in people with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, run by MSD R&D (China) Co., Ltd. at 15 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants who Experience a Dose-limiting Toxicity (DLT) (time frame: Up to ~28 Days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06189391.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in