NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

Not Yet RecruitingPhase 2

Sponsor: Merck Sharp & Dohme LLC

Conditions: Chronic Lymphocytic Leukaemia, Small Lymphocytic Lymphoma, Hematologic Malignancies

Interventions: MK-1045, Acetaminophen (or similar antipyretic), Diphenhydramine (or similar antihistamine), Dexamethasone, Tocilizumab

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.