NCT07643805尚未招募1 期
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
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2026年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 46
- 试验地点
- 1
研究概览
简要总结
Single-Arm Clinical Study of Zeprumetostat in Combination with Glofitamab + GemOx in Patients with Relapsed/ Refractory DLBCL
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
Lei Fan
Director of lymphoma center
The First Affiliated Hospital with Nanjing Medical University
研究点 (1)
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