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Chronic Lymphocytic LeukaemiaPhase 2NCT07709000

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

A Phase 2 study testing MK-1045, Acetaminophen (or similar antipyretic) and Diphenhydramine (or similar antihistamine) in people with Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma, run by Merck Sharp & Dohme LLC at 7 sites in 2 countries.

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 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MK-1045, Acetaminophen (or similar antipyretic) and Diphenhydramine (or similar antihistamine)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
7 sitesin 2 countries
Study dates
14 Oct 2026to 16 Nov 2033
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

7 sites in 2 countries. 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

7 sites in 2 countries

Israel5 sites, 5 recruiting

  • Rambam Health Care Campus ( Site 0803)

    Haifa, 3109601

    Study Coordinator, +97247771514

    Recruiting

  • Shaare Zedek Medical Center ( Site 0801)

    Jerusalem, 9103102

    Study Coordinator, +972-2-5645462

    Recruiting

  • Haddasah Medical Center ( Site 0800)

    Jerusalem, 9112001

    Study Coordinator, +972539101736

    Recruiting

  • Sheba Medical Center ( Site 0802)

    Ramat Gan, 5265601

    Study Coordinator, 97235303030

    Recruiting

  • Sourasky Medical Center ( Site 0804)

    Tel Aviv, 6423906

    Study Coordinator, +97236974444

    Recruiting

Other trials in Israel

Colombia2 sites, 2 recruiting

  • Los Cobos Medical Center ( Site 0607)

    Bogotá, Bogota D.C., 110121

    Study Coordinator, +573015917907

    Recruiting

  • Hospital Pablo Tobon Uribe ( Site 0601)

    Medellín, Antioquia, 50034

    Study Coordinator, +573148905603

    Recruiting

Other trials in Colombia

About this study

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

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.
Being tested
MK-1045, Acetaminophen (or similar antipyretic), Diphenhydramine (or similar antihistamine), Dexamethasone, Tocilizumab
Medical subject headings
Leukemia, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Hematologic Neoplasms

What participants receive

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

  • MK-1045Biological

    Also called CN201

    Intravenous (IV) infusion

  • Acetaminophen (or similar antipyretic)Drug

    Oral administration as a premedication

  • Diphenhydramine (or similar antihistamine)Drug

    Per approved product label as a premedication

  • DexamethasoneDrug

    IV administration as a premedication

  • TocilizumabBiological

    IV administration as a rescue medication

  • Tocilizumab biosimilarBiological

    Also called Avtozma®, Tyenne®

    IV administration as a rescue medication

  • SiltuximabBiological

    IV administration as a rescue medication

Study groups in NCT07709000
Study groupRoleWhat they receive
Part 1: Dose FindingExperimentalParticipants 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.
Receives: 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 ExpansionExperimentalParticipants 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.
Receives: Biological: MK-1045; Drug: Acetaminophen (or similar antipyretic); Drug: Diphenhydramine (or similar antihistamine); Drug: Dexamethasone; Biological: Tocilizumab; Biological: Tocilizumab biosimilar; Biological: Siltuximab

What is being measured

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

  1. 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.

    Measured: Up to approximately 29 days

  2. 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.

    Measured: Up to approximately 27 months

  3. 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.

    Measured: Up to approximately 24 months

  4. 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).

    Measured: Up to approximately 66 months

Secondary outcomes (8)

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

    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.

    Measured: Up to approximately 27 months

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

    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.

    Measured: Up to approximately 24 months

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

    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.

    Measured: Up to approximately 66 months

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Timeline

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

  1. First posted16 Jul 2026
  2. Study start14 Oct 2026
  3. Primary completion16 Nov 2033 (estimated)
  4. Study completion16 Nov 2033 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07709000
Sponsor's protocol ID
1045-006
Other IDs
2025-522242-49-00, U1111-1322-3169, MK-1045-006, 2025
Status last verified
Oct 2026
First submitted
13 Jul 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
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 2 study testing MK-1045, Acetaminophen (or similar antipyretic) and Diphenhydramine (or similar antihistamine) in people with Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma, run by Merck Sharp & Dohme LLC at 7 sites in 2 countries.

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 5 inclusion and 10 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Israel, Colombia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Cohort A Part 1: Number of Participants Who Experience Dose-Limiting Toxicity (DLT) (time frame: Up to approximately 29 days). The study lists 4 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 NCT07709000.

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 4 Nov 2026.

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