NCT07709000RecruitingPhase 2
A Clinical Trial of MK-1045 in People With B-cell Cancer (MK-1045-006)
A Phase 2, Open-label, Multicenter Study to Determine the Safety, Tolerability, and Efficacy of MK-1045 in Participants With Hematologic Malignancies
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 13 Jul 2026
- Start date
- 14 Oct 2026
- Primary completion date
- 16 Nov 2033
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT07709000
- EU CT number
- 2025-522242-49-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 14 Oct 2026 to the primary completion date, 16 Nov 2033
- 7 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has not adequately recovered from major surgery or has ongoing surgical complications.
Other illness
- 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 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.
Other
- Has a diagnosis of immunodeficiency.
- Has a diagnosis of Richter Transformation.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Los Cobos Medical Center ( Site 0607) Coordinator of this site? Confirm its status | Bogotá | Colombia | Recruiting |
| Hospital Pablo Tobon Uribe ( Site 0601) Coordinator of this site? Confirm its status | Medellín | Colombia | Recruiting |
| Rambam Health Care Campus ( Site 0803) Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Haddasah Medical Center ( Site 0800) Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Shaare Zedek Medical Center ( Site 0801) Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Sheba Medical Center ( Site 0802) Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Sourasky Medical Center ( Site 0804) Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.