NCT04456023撤回2 期
A Phase II, Single-arm, Multicenter Trial to Evaluate the Efficacy and Safety of Tisagenlecleucel in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-cell Non-Hodgkin Lymphoma (DLBCL)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This is a multi-center, phase II study to evaluate the efficacy and safety of CTL019 in Chinese adult patients with relapsed or refractory DLBCL.
详细描述
Disease assessments will be performed at screening, after bridging, 1, 3, 6, 9 and 12 months after tisagenlecleucel infusion, and every 6 months in the second year, and annually up to 60 months after infusion. Efficacy will be assessed until progression; safety will be assessed throughout the study. A long term follow-up up to 15 years after CTL019 infusion will continue under a separate protocol (CCTL019A2205B)(NCT02445222).
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
- •Signed informed consent must be obtained prior to participation in the study
- •Patients must be ≥18 years of age at the time of ICF signature
- •Histologically confirmed DLBCL at last relapse (including DLBCL transformed from follicular lymphoma and double-triple hit lymphoma)
- •Relapsed or refractory disease after at least 2 lines of systemic therapy, including anti-CD20 antibody and an anthracycline, or having failed or being ineligible for autologous HSCT
- •ECOG performance status that is either 0 or 1 at screening
- •Measurable disease at time of enrollment:
- •Nodal lesions greater than 15 mm in the long axis, regardless of the length of the short axis or
- •Extra nodal lesion (outside lymph node or nodal mass, but including liver and spleen) at least 10 mm in long and short axis
- •Adequate organ function
- •Must have a leukapheresis material of non-mobilized cells available for manufacturing
排除标准
- •Prior treatment with anti-CD19 therapy, adoptive T cell therapy, or any prior gene therapy product
- •Primary mediastinal large B-cell lymphoma, EBV+ DLBCL, Richter's transformation, Burkitt lymphoma, primary DLBCL of CNS, T cell / histiocyte rich large B-cell lymphoma, primary cutaneous DLBCL.
- •Eligible for and consenting to autologous HSCT
- •Prior allogeneic SCT
- •Active CNS involvement by disease under study, except if the CNS involvement has been effectively treated (i.e. patient is asymptomatic) and local treatment was greater than 4 weeks before enrollment
- •Active neurological autoimmune or inflammatory disorders (e.g. Guillain-Barre syndrome)
- •Investigational medicinal product within the last 30 days or five half-lives (whichever is longer) prior to screening
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months
Complete Response (CR) and Partial Response (PR) according to the Lugano classification as determined by the Investigator.
次要结局
- Overall Survival (OS)(From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months)
- Duration of Response (DOR)(From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months)
- Time to response (TTR)(From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months)
- Progression-Free Survival (PFS)(From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months)
- Event free survival (EFS)(From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months)
- Number of Participants with On-Treatments Adverse Events, Serious Adverse Events, and Deaths(From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months)
- Tisagenlecleucel immunogenicity (humoral)(Up to Month 60)
- In vivo cellular PK profile of tisagenelecleucel(Up to Month 60)
- Tisagenlecleucel immunogenicity (cellular)(Up to Month 60)
- Concentration of Tocilizumab PK in tocilizumab treated subjects during CRS(Up to Day 7 after tocilizumab infusion)
- Serum cytokines (IL-10, interferon gamma, IL-6, CRP and ferritin)(Up to Month 60)
研究者
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