A Clinical Trial of MK-1045 in People With B-cell Cancer (MK-1045-006)
NCT07709000 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-07-16
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.
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.
Conditions
Interventions
- BIOLOGICAL
-
MK-1045
Intravenous (IV) infusion
- DRUG
-
Acetaminophen (or similar antipyretic)
Oral administration as a premedication
- DRUG
-
Diphenhydramine (or similar antihistamine)
Per approved product label as a premedication
- DRUG
-
IV administration as a premedication
- BIOLOGICAL
-
IV administration as a rescue medication
- BIOLOGICAL
-
Tocilizumab biosimilar
IV administration as a rescue medication
- BIOLOGICAL
-
Siltuximab
IV administration as a rescue medication
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-21
- Primary Completion
- 2033-11-16
- Completion
- 2033-11-16
- FDA Drug
- Yes
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