CTIS2022-502661-23-00进行中（未招募）1 期
A phase I/II, multicenter study evaluating the feasibility, safety, and efficacy of point-of-care manufactured GLPG5101 (19CP02) in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma - CP0201-NH
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Galapagos
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Signed informed consent form, 2. Age = 18 years, 3.1 Histologically confirmed diagnosis of one of the following non-Hodgkin lymphoma subtypes: Aggressive DLBCL, FL grade 1, 2 or 3A, MZL, or MCL, BL, PCNSL, 4.1 Relapsed or refractory disease, 5.1 Measurable disease according to the Lugano classification or IPCG criteria for PCNSL, 6. ECOG performance status of 0-2 (Subjects with ECOG 2 must have serum albumin = 3.4 g/dL), 7 & 8. Adequate bone marrow, renal, hepatic and pulmonary function
排除标准
- •Richter's transformation, Selected prior treatments as defined in the protocol, History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 3 years (exceptions per protocol), Active CNS involvement (with neurological changes) by disease under study, Infection with HIV, hepatitis B or hepatitis C virus
研究者
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