EUCTR2021-005725-24-DK进行中（未招募）1 期
Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination with Anti-Neoplastic Agents in Subjects with Non-Hodgkin Lymphoma - Non-Hodgkin Lymphoma: Epcoritamab in Combination with Anti-Neoplastic Agents
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 394
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Adult male or female, at least 18 years old
- •2. (Arms 1, 2, 3, and 4) Diagnosis of DLBCL (de novo or histologically transformed from follicular lymphoma or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to World Health Organization (WHO) 2016 classification and documented in pathology report:
- •DLBCL, NOS
- •High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per WHO 2016 (double-hit” or triple-hit”)
- •Note: High-grade B-cell lymphomas NOS or other double-/triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible
- •FL Grade 3B
- •3. Subject must have Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2 except for Arms 6 and 7 where ECOG performance status must be 0-1.
- •4. Subject must have 1 or more measurable disease sites:
- •A PET/CT scan demonstrating PET-positive lesion(s)
- •At least 1 measurable nodal lesion (long axis = 1.5cm) or = 1 measurable extra-nodal lesion (long axis = 1.0 cm) on CT scan or MRI
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 394
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1.Diagnosis of High-grade B-cell lymphomas NOS or other double-/triple-hit lymphomas (with histologies not consistent with DLBCL)
- •2. Subjects who have had prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20
研究者
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