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

NCT07709000 | Not Yet Recruiting Phase 2 FDA Drug

• 4 other identifiers: 1045-0062025-522242-49U1111-1322-3169MK-1045-006
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Lymphocytic Leukaemia; Small Lymphocytic Lymphoma; Hematologic Malignancies

Outcome Measures

Primary Outcomes (4)

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

  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.

  Up to approximately 29 days

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

  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.

  Up to approximately 27 months

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

  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.

  Up to approximately 24 months

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

  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).

  Up to approximately 66 months

Secondary Outcomes (8)

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

  Up to approximately 27 months

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

  Up to approximately 24 months

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

  Up to approximately 66 months

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

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

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

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

Study Arms (2)

Part 1: Dose Finding

EXPERIMENTAL

Participants will receive a step-up dosing regimen of MK-1045. During Cycle 1, participants will receive priming dose 1 of 1 mg MK-1045 on Day 1, priming dose 2 of 5 mg MK-1045 on Day 4, intermediate dose of 20 mg MK-1045 on Day 8, and then weekly (QW) target dose of 40-90 mg MK-1045 thereafter for up to approximately 2 years. At the discretion of physician investigator and after Sponsor consultation, participants who receive at least 3, 4-week treatment cycles and achieve a complete response may switch to an every two-weeks (Q2W) dosing regimen.

Biological: MK-1045; Drug: Acetaminophen (or similar antipyretic); Drug: Diphenhydramine (or similar antihistamine); Drug: Dexamethasone; Biological: Tocilizumab; Biological: Tocilizumab biosimilar; Biological: Siltuximab

Part 2: Dose Expansion

EXPERIMENTAL

Participants will receive MK-1045 QW at the recommended dose determined in Part 1 for up to approximately 2 years. At the discretion of physician investigator and after Sponsor consultation, participants who receive at least 3, 4-week treatment cycles and achieve a complete response may switch to a Q2W dosing regimen.

Biological: MK-1045; Drug: Acetaminophen (or similar antipyretic); Drug: Diphenhydramine (or similar antihistamine); Drug: Dexamethasone; Biological: Tocilizumab; Biological: Tocilizumab biosimilar; Biological: Siltuximab

Interventions

MK-1045 BIOLOGICAL

Intravenous (IV) infusion

Also known as: CN201

Part 1: Dose Finding; Part 2: Dose Expansion

Acetaminophen (or similar antipyretic) DRUG

Oral administration as a premedication

Part 1: Dose Finding; Part 2: Dose Expansion

Diphenhydramine (or similar antihistamine) DRUG

Per approved product label as a premedication

Part 1: Dose Finding; Part 2: Dose Expansion

Dexamethasone DRUG

IV administration as a premedication

Part 1: Dose Finding; Part 2: Dose Expansion

Tocilizumab BIOLOGICAL

IV administration as a rescue medication

Part 1: Dose Finding; Part 2: Dose Expansion

Tocilizumab biosimilar BIOLOGICAL

IV administration as a rescue medication

Also known as: Avtozma®, Tyenne®

Part 1: Dose Finding; Part 2: Dose Expansion

Siltuximab BIOLOGICAL

IV administration as a rescue medication

Part 1: Dose Finding; Part 2: Dose Expansion

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Leukemia, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell; Hematologic Neoplasms

Interventions

Acetaminophen; Diphenhydramine; Dexamethasone; tocilizumab; siltuximab

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethylamines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start (Estimated): August 21, 2026
• Primary Completion (Estimated): November 16, 2033
• Study Completion (Estimated): November 16, 2033
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share