EUCTR2021-003272-13-NL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 19CP02 in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma - Atalanta-1
CellPoint B.V.0 个研究点目标入组 45 人开始时间: 2021年6月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
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. Signed informed consent form
- •2. Age = 18 years
- •3. Histologically confirmed diagnosis of one of the following non-Hodgkin lymphoma subtypes: DLBCL, FL grade 1, 2 or 3A, MZL, or MCL
- •4. Relapsed or refractory disease
- •5. Measurable disease according to the Lugano classification
- •6. ECOG performance status of 0 or 1 (ECOG 2 is allowed if due to underlying disease)
- •7. Adequate bone marrow, renal, hepatic and pulmonary function
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Primary CNS B-cell lymphoma, Burkitt lymphoma, or Richter’s transformation
- •2. Selected prior treatments as defined in the protocol
- •3. History of malignancy other than lymphoma (exceptions per protocol)
- •4. Active CNS involvement (with neurological changes) by disease under study
- •5. Infection with HIV, hepatitis B or hepatitis C virus
研究者
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