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

ClinicalTrials.gov ID

NCT07709000

Lead Sponsor

Merck Sharp & Dohme LLCINDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

60Estimated

Last Update Posted

Aug 27, 2026Actual

Start Date

Sep 11, 2026Estimated

Primary Completion Date

Nov 16, 2033Estimated

Completion Date

Nov 16, 2033Estimated

Official Title

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

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.

• Chronic Lymphocytic Leukaemia
• Small Lymphocytic Lymphoma
• Hematologic Malignancies

• MK-1045
• Acetaminophen (or similar antipyretic)
• Diphenhydramine (or similar antihistamine)
• Dexamethasone
• Tocilizumab
• Tocilizumab biosimilar
• Siltuximab

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Non-Randomized

Interventional Model

Sequential Assignment

Masking

Single

Lead Sponsor

Merck Sharp & Dohme LLCINDUSTRY

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