Application of the Autologous CAR T Cells (Tarcidomgen Kimleucel) in the Treatment of Refractory and Relapsed CD19+ B Cell Neoplasms
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Percentage of patients with CRS in particular degree of severity according to ASTCT neurological side effects, febrile neutropenia and infection, cytopenia, other unspecified adverse events and death
研究概览
简要总结
One arm, open label study to assess the clinical use of Investigational Medicinal Product FCTX-CL19-1 (scientific name: Tarcidomgen Kimleucel) containing autologous anti-CD19 CAR T cells with a preliminary determination of the safety of intravenous IMP administration in patients diagnosed with refractory and relapsed CD19 + B cell neoplasms.
详细描述
The aim of the study is to determine the safety of therapy with the study medicinal product FCTX-CL19-1 (Tarcidomgen Kimleucel) with preliminary determination of efficacy, as part of a phase I clinical trial in patients with relapsed and refractory B-cell CD19+ tumors.
The hypothesis of the study assumes that the use of the newly developed product FCTX-CL19-1 (Tarcidomgen Kimleucel) containing autologous anti-CD19 CAR T cells is safe and will lead to remission of B-cell cancer resistant to current treatment.
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 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
FCTX-CL19-1 (Tarcidomgen Kimleucel)
FCTX-CL19-1 (Tarcidomgen Kimleucel) - active IMP - consists of autologous T-cells with chimeric antigen receptor (CAR), Advanced Therapy Medicinal Product, ATMP, Gene Therapy Medicinal Product, GTMP
干预措施: FCTX-CL19-1 (Tarcidomgen Kimleucel) (Biological)
结局指标
主要结局
Percentage of patients with CRS in particular degree of severity according to ASTCT neurological side effects, febrile neutropenia and infection, cytopenia, other unspecified adverse events and death
时间窗: through study completion, an average of 1 year
Safety assessment of IMP administration as the percentage of patients with cytokine release syndrome (CRS) in particular degree of severity according to ASTCT, neurological side effects, febrile neutropenia and infection, cytopenia, other unspecified adverse events and death as a result of the side effects and adverse events described within a 1 month after IMP administration
次要结局
- Percentage of participants with response to the therapy (sum of complete remissions and partial responses in the particular malignancies)(through study completion, an average of 1 year)
- Percentage of participants with no possibility to receive the product due to the production failure(through study completion, an average of 1 year)
研究者
CARLA punkt kontaktowy
Scientific
Famicordtx S.A.