EZH2 Inhibitor Zeprumetostat in Combination Therapy for Patients With Relapsed or Refractory Mature T-cell and NK-cell Lymphomas

Официальное название

An Open-label, Multicenter, Exploratory Clinical Study of the EZH2 Inhibitor Zeprumetostat in Combination Therapy for Patients With Relapsed or Refractory Mature T-cell and NK-cell Lymphomas.

Обзор

This is a prospective, multicenter, open-label, phase Ib/II clinical study to evaluate the safety and efficacy of EZH2 inhibitor Zeprumetostat in combination therapy for patients with relapsed or refractory mature T-cell and NK-cell lymphomas.

Вмешательства

• Препарат Zeprumetostat
  350mg, po, bid
• Препарат Golidocitinib
  Cohort 1: Golidocitinib: 150mg, po, qd
• Препарат Chidamide
  Cohort 2: Chidamide: 20mg, po, biw

Первичные конечные точки

• DLT for Phase 1b [Срок оценки: The first cycle after administration (each cycle is 28 days)]
• Overall response rate(ORR) for Phase 2 [Срок оценки: Up to 24 months]
• RP2D for phase Ib [Срок оценки: The first cycle after administration (each cycle is 28 days)]

Вторичные конечные точки (4)

• Complete response rate (CRR) [Срок оценки: Up to 24 months]
• Duration of Response(DOR) [Срок оценки: Up to 4 years]
• Progression-free survival(PFS) [Срок оценки: Up to 4 years]
• Overall survival(OS) [Срок оценки: Up to 4 years]

Критерии участия

Критерии включения

• Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the Informed Consent Form (ICF); willing to comply with and capable of completing all trial procedures;
• Age ≥ 18 years
• Pathologically confirmed mature T-cell and NK-cell lymphomas.
• Using the Lugano 2014 criteria, the patient must have at least one measurable or evaluable lesion
• Participants must have experienced disease progression, treatment failure, or intolerance following standard therapy. Patients with ALCL are required to have previously received anti-CD30-targeted therapy, while patients with NKTCL must have previously been treated with pegaspargase or L-asparaginase.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Adequate organ and bone marrow function

Критерии исключения

• Lymphoma involvement in the central nervous system or meninges
• Active infections
• Prior treatment with an EZH2 inhibitor or an EZH1/2 dual inhibitor that was discontinued due to intolerance to toxicity;
• For patients enrolled in Cohort 1, prior treatment with a JAK inhibitor that was discontinued due to intolerance to toxicity;
• For patients enrolled in Cohort 2, prior treatment with an HDAC inhibitor that was discontinued due to intolerance to toxicity.
• History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
• Patients with mental disorders or those unable to provide informed consent
• Any other condition deemed by the investigator to be unsuitable for study enrollment;
• Pregnant or breastfeeding women, and subjects of childbearing potential who are unwilling to use contraception;
• Individuals with a known hypersensitivity to any of the investigational drugs.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07339527 · B2025-804

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗