Single-Arm Clinical Study of EZH2i in Combination With Glofitamab + GemOx in Patients With Relapsed/ Refractory DLBCL

Официальное название

A Prospective, Single-Arm, Phase Ib/II Clinical Study of the EZH2 Inhibitor in Combination With Glofitamab Plus GemOx for the Treatment of Relapsed/Refractory DLBCL

Обзор

Single-Arm Clinical Study of Zeprumetostat in Combination with Glofitamab + GemOx in Patients with Relapsed/ Refractory DLBCL

Вмешательства

• Препарат EZH2i+GLofit-GemOx
  EZH2i+GLofit-GemOx

Первичные конечные точки

• Complete response rate, CRR [Срок оценки: From first dose to end of treatment (assessed up to 12 months)]

Критерии участия

Критерии включения

• Age ≥ 18 years, male or female;
• Histologically confirmed diffuse large B-cell lymphoma (DLBCL);
• Relapsed/refractory (R/R) disease；
• At least one prior line of therapy containing rituximab;
• Subjects must have at least one measurable lesion;
• ECOG PS 0-2;
• Life expectancy ≥ 3 months;
• Adequate organ and bone marrow function, without severe hematopoietic abnormalities or cardiac, pulmonary, hepatic, renal, thyroid dysfunction, or immunodeficiencies;
• Female subjects of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose of study drug; WOCBP subjects and male subjects with WOCBP partners must agree to practice effective contraceptive measures from the time of signing the informed consent form (ICF) until 6 months after the last dose of study drug;
• Signed informed consent form (ICF), voluntarily agreeing to participate in this study.

Критерии исключения

• Patient is a candidate for hematopoietic stem cell transplantation.
• Prior allogeneic hematopoietic stem cell transplantation.
• Primary or secondary central nervous system (CNS) lymphoma or history of CNS lymphoma.
• History of severe hypersensitivity or anaphylactic reaction to humanized or murine monoclonal antibodies.
• Prior treatment with an EZH2 inhibitor, and/or an anti-CD20 and CD3 bispecific antibody, and/or GemOx (gemcitabine and oxaliplatin).
• History of other malignancies within the past 2 years requiring systemic therapy.
• Receipt of systemic anti-neoplastic therapy, including chemotherapy, immunotherapy, biologic therapy, etc., within 14 days prior to the start of study treatment.
• Major surgery (excluding diagnostic procedures) within 28 days prior to the start of study treatment.
• Presence of any active, known, or suspected autoimmune disease. (Subjects who are in a stable condition and do not require systemic immunosuppressive therapy are permitted to enroll.)
• Use of immunosuppressive agents, including systemic corticosteroids, within 14 days prior to study drug administration (use of ≤10 mg/day prednisone or equivalent is permitted).
• Any active infection requiring systemic anti-infective therapy within 14 days prior to the start of study treatment.
• Presence of any uncontrolled comorbid conditions that may affect compliance with the study protocol, including major cardiovascular disease, bleeding disorders, etc.
• Active hepatitis B virus (HBV) infection (HBV DNA positive) or hepatitis C virus (HCV) infection.
• Known history of human immunodeficiency virus (HIV) positivity.
• Inability to swallow oral medication, or any other factor affecting oral drug administration and absorption.
• Known history of hypersensitivity to the study drug.
• Pregnant or breastfeeding women.
• Any other condition deemed inappropriate for inclusion by the investigator.

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

Китай · 1 центр

• The First Affiliated Hospital with Nanjing Medical University — Нанкин

Идентификаторы

NCT: NCT07643805 · MA-DLBCL-II-005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗