MK-1045-006: testing a new treatment for B-cell cancers like CLL and SLL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial evaluating MK-1045 in patients with B-cell cancers such as CLL and SLL. Participants may receive adjunct medications (acetaminophen, diphenhydramine, dexamethasone, and tocilizumab) as part of the protocol. The study aims to determine safety and tolerability and to measure response rates, defined by decreases in cancer cells or disappearance of signs of cancer. Eligible participants must have confirmed CD19‑positive, relapsed/refractory disease and meet specified health criteria, while certain cardiovascular, CNS, immunodeficiency, and other cancer conditions exclude enrollment. The study is sponsored by Merck Sharp & Dohme LLC with three international sites.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Pablo Tobon Uribe ( Site 0601)
  Medellín, Antioquia, Colombia Recruiting
• Los Cobos Medical Center ( Site 0607)
  Bogotá, Bogota D.C., Colombia Recruiting
• Rambam Health Care Campus ( Site 0803)
  Haifa, Israel Recruiting
• Shaare Zedek Medical Center ( Site 0801)
  Jerusalem, Israel Recruiting
• Haddasah Medical Center ( Site 0800)
  Jerusalem, Israel Recruiting
• Sheba Medical Center ( Site 0802)
  Ramat Gan, Israel Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.