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 5 sites in Israel.
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
- Conditions the study is for
- Chronic Lymphocytic Leukaemia, Small Lymphocytic Lymphoma, Hematologic Malignancies
- What is being tested?
- MK-1045, Acetaminophen (or similar antipyretic) and Diphenhydramine (or similar antihistamine)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesIsrael
- Study dates
- 9 Oct 2026to 16 Nov 2033
- Phase
- Phase 2
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.
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- 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
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Israel5 sites
Rambam Health Care Campus ( Site 0803)
Haifa, 3109601
Study Coordinator, +97247771514
Shaare Zedek Medical Center ( Site 0801)
Jerusalem, 9103102
Study Coordinator, +972-2-5645462
Haddasah Medical Center ( Site 0800)
Jerusalem, 9112001
Study Coordinator, +972539101736
Sheba Medical Center ( Site 0802)
Ramat Gan, 5265601
Study Coordinator, 97235303030
Sourasky Medical Center ( Site 0804)
Tel Aviv, 6423906
Study Coordinator, +97236974444
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 group | Role | What they receive |
|---|---|---|
| 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. 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 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. 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.
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
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
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
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)
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
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
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
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)
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)
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)
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)
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.
- First posted16 Jul 2026
- Study start9 Oct 2026 (estimated)
- Primary completion16 Nov 2033 (estimated)
- Study completion16 Nov 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukaemiaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
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
- 8 Oct 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