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NCT Number: NCT07709000

A Clinical Trial of MK-1045 in People With B-cell Cancer (MK-1045-006)

Researchers are looking for new ways to treat people with B-cell cancers. In this trial, researchers will look at chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). These are blood cancers that affect B-cells in the blood, bone marrow, or lymph nodes.

The goals of this trial are to learn about:

* The safety of MK-1045 and if participants tolerate it. Tolerate means participants will receive trial treatment unless they need to stop treatment due to health problems. * The number of participants who respond. Respond means the number of cancer cells goes down or signs of cancer go away.

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Key information

Conditions

Chronic Lymphocytic Leukaemia Chronic Disease Disease Attributes Hematologic Diseases Hematologic Malignancies Hematologic Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Small Lymphocytic Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has histologically confirmed chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) active disease that is relapsed/refractory (r/r) to prior therapy.
  • Has confirmed CD19-positive disease.
  • If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy.
  • If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load.
  • If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.

Exclusion criteria

  • Has a history of serious cardiovascular and cerebrovascular diseases.
  • Has a history or presence of central nervous system disease.
  • Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
  • Has a diagnosis of immunodeficiency.
  • Has a known additional malignancy that is progressing or required active treatment within the past 2 years.
  • Has active autoimmune disease (not related to underlying leukemia diagnosis) that required systemic treatment in the past 2 years.
  • Has any active acute graft versus host disease (GvHD) or active chronic GvHD requiring systemic treatment.
  • Has active infection requiring systemic therapy.
  • Has not adequately recovered from major surgery or has ongoing surgical complications.
  • Has a diagnosis of Richter Transformation.

Treatment and study plan

MK-1045

Biological

Intravenous (IV) infusion

Other names: CN201

Acetaminophen (or similar antipyretic)

Drug

Oral administration as a premedication

Diphenhydramine (or similar antihistamine)

Drug

Per approved product label as a premedication

Dexamethasone

Drug

IV administration as a premedication

Tocilizumab

Biological

IV administration as a rescue medication

Tocilizumab biosimilar

Biological

IV administration as a rescue medication

Other names: Avtozma®, Tyenne®

Siltuximab

Biological

IV administration as a rescue medication

Primary outcomes

  1. Cohort A Part 1: Number of Participants Who Experience Dose-Limiting Toxicity (DLT)

    Time frame: Up to approximately 29 days

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

  2. Cohort A Part 1: Number of Participants Who Experience an AE

    Time frame: Up to approximately 27 months

    An AE is defined as 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.

  3. Cohort A Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 24 months

    An AE is defined as 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.

  4. Cohort A Parts 1 and 2: Objective Response Rate (ORR)

    Time frame: Up to approximately 66 months

    ORR is defined as the percentage of participants with complete response (CR), complete response with an incomplete recovery of the participant's bone marrow (CRi), nodular partial response (nPR), or partial response (PR), per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by blinded independent central review (BICR).

Secondary outcomes

  1. Cohort A Part 2: Number of Participants Who Experience an AE

    Time frame: Up to approximately 27 months

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

  2. Cohort A Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 24 months

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

  3. Cohort A Parts 1 and 2: Duration of Response (DOR)

    Time frame: Up to approximately 66 months

    For participants who demonstrate a CR, CRi, nPR, or PR per iwCLL Criteria 2018 as assessed by BICR, DOR is defined as the time from the first documented evidence of CR, CRi, nPR, or PR until disease progression or death due to any cause, whichever occurs first.

  4. Cohort A Parts 1 and 2: Area Under the Curve at Steady State (AUCss) of MK-1045

    Time frame: Predose and at designated time points post-dose (up to approximately 24 months)

    Blood samples will be collected at designated timepoints to estimate the AUCss of MK-1045.

  5. Cohort A Parts 1 and 2: Maximum Concentration (Cmax) of MK-1045

    Time frame: Predose and at designated time points post-dose (up to approximately 24 months)

    Blood samples will be collected at designated timepoints to estimate the Cmax of MK-1045.

  6. Cohort A Parts 1 and 2: Concentration Immediately Before the Next Dose Is Administered (Ctrough) of MK-1045

    Time frame: Predose and at designated time points post-dose (up to approximately 24 months)

    Blood samples will be collected at designated timepoints to estimate the Ctrough of MK-1045.

  7. Cohort A Parts 1 and 2: Percentage of Participants Who Develop Antidrug Antibodies (ADA) to MK-1045

    Time frame: Predose and at designated time points post-dose (up to approximately 24 months)

    Blood samples collected at designated timepoints will be used to determine the percentage of participants who develop detectable ADAs to MK-1045.

  8. Cohort A Parts 1 and 2: Percentage of Participants Who Develop MK-1045 Neutralizing Antibodies (NAb)

    Time frame: Predose and at designated time points post-dose (up to approximately 24 months)

    Blood samples collected at designated timepoints will be used to determine the percentage of participants who develop detectable NAbs to MK-1045.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 2, Open-label, Multicenter Study to Determine the Safety, Tolerability, and Efficacy of MK-1045 in Participants With Hematologic Malignancies

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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