Clinical trial · Interventional
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
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukaemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetaminophen (or similar antipyretic) | Drug | — | UNRESOLVED |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Diphenhydramine (or similar antihistamine) | Drug | — | UNRESOLVED |
| MK-1045 | Biological | — | UNRESOLVED |
| Siltuximab | Biological | — | UNRESOLVED |
| Tocilizumab | Biological | — | UNRESOLVED |
| Tocilizumab biosimilar | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1: Dose Finding
- description
- 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.
- interventionNames
- Biological: MK-1045
- Drug: Acetaminophen (or similar antipyretic)
- Drug: Diphenhydramine (or similar antihistamine)
- Drug: Dexamethasone
- Biological: Tocilizumab
- Biological: Tocilizumab biosimilar
- Biological: Siltuximab
- type
- EXPERIMENTAL
- label
- Part 2: Dose Expansion
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available