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

Официальное название

A Phase 2, Open-label, Multicenter Study to Determine the Safety, Tolerability, and Efficacy of MK-1045 in Participants With Hematologic Malignancies

Обзор

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.

Вмешательства

• Биопрепарат MK-1045
  Intravenous (IV) infusion
• Препарат Acetaminophen (or similar antipyretic)
  Oral administration as a premedication
• Препарат Diphenhydramine (or similar antihistamine)
  Per approved product label as a premedication
• Препарат Dexamethasone
  IV administration as a premedication
• Биопрепарат Tocilizumab
  IV administration as a rescue medication
• Биопрепарат Tocilizumab biosimilar
  IV administration as a rescue medication
• Биопрепарат Siltuximab
  IV administration as a rescue medication

Первичные конечные точки

• Cohort A Part 1: Number of Participants Who Experience Dose-Limiting Toxicity (DLT) [Срок оценки: Up to approximately 29 days]
• Cohort A Part 1: Number of Participants Who Experience an AE [Срок оценки: Up to approximately 27 months]
• Cohort A Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE [Срок оценки: Up to approximately 24 months]
• Cohort A Parts 1 and 2: Objective Response Rate (ORR) [Срок оценки: Up to approximately 66 months]

Вторичные конечные точки (8)

• Cohort A Part 2: Number of Participants Who Experience an AE [Срок оценки: Up to approximately 27 months]
• Cohort A Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE [Срок оценки: Up to approximately 24 months]
• Cohort A Parts 1 and 2: Duration of Response (DOR) [Срок оценки: Up to approximately 66 months]
• Cohort A Parts 1 and 2: Area Under the Curve at Steady State (AUCss) of MK-1045 [Срок оценки: Predose and at designated time points post-dose (up to approximately 24 months)]
• Cohort A Parts 1 and 2: Maximum Concentration (Cmax) of MK-1045 [Срок оценки: Predose and at designated time points post-dose (up to approximately 24 months)]
• Cohort A Parts 1 and 2: Concentration Immediately Before the Next Dose Is Administered (Ctrough) of MK-1045 [Срок оценки: Predose and at designated time points post-dose (up to approximately 24 months)]
• Cohort A Parts 1 and 2: Percentage of Participants Who Develop Antidrug Antibodies (ADA) to MK-1045 [Срок оценки: Predose and at designated time points post-dose (up to approximately 24 months)]
• Cohort A Parts 1 and 2: Percentage of Participants Who Develop MK-1045 Neutralizing Antibodies (NAb) [Срок оценки: Predose and at designated time points post-dose (up to approximately 24 months)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07709000 · 1045-006 · 2025-522242-49 · U1111-1322-3169 · MK-1045-006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗