A Clinical Trial of MK-1045 in People With B-cell Cancer (MK-1045-006)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MK-1045, Acetaminophen (or similar antipyretic), Diphenhydramine (or similar antihistamine), Dexamethasone.
- Who it may be relevant to
- Registry conditions: Chronic Lymphocytic Leukaemia, Small Lymphocytic Lymphoma, Hematologic Malignancies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2, Open-label, Multicenter Study to Determine the Safety, Tolerability, and Efficacy of MK-1045 in Participants With Hematologic Malignancies
Overview
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.
Interventions
- Biological MK-1045
Intravenous (IV) infusion - Drug Acetaminophen (or similar antipyretic)
Oral administration as a premedication - Drug Diphenhydramine (or similar antihistamine)
Per approved product label as a premedication - Drug Dexamethasone
IV administration as a premedication - Biological Tocilizumab
IV administration as a rescue medication - Biological Tocilizumab biosimilar
IV administration as a rescue medication - Biological Siltuximab
IV administration as a rescue medication
Primary outcome measures
- Cohort A Part 1: Number of Participants Who Experience Dose-Limiting Toxicity (DLT) [Time frame: Up to approximately 29 days]
- Cohort A Part 1: Number of Participants Who Experience an AE [Time frame: Up to approximately 27 months]
- Cohort A Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE [Time frame: Up to approximately 24 months]
- Cohort A Parts 1 and 2: Objective Response Rate (ORR) [Time frame: Up to approximately 66 months]
Secondary outcome measures (8)
- Cohort A Part 2: Number of Participants Who Experience an AE [Time frame: Up to approximately 27 months]
- Cohort A Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE [Time frame: Up to approximately 24 months]
- Cohort A Parts 1 and 2: Duration of Response (DOR) [Time frame: Up to approximately 66 months]
- 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)]
- 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)]
- 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)]
- 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)]
- 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)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07709000 · 1045-006 · 2025-522242-49 · U1111-1322-3169 · MK-1045-006