Continuous Alloreactive T Cell Depletion and Regulatory T Cell Expansion for the Treatment of Steroid-refractory or Dependent Chronic GVHD
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- The primary endpoint is failure-free survival (FFS) at 24 weeks
研究概览
简要总结
Phase II multicenter, Canadian only study - open to 25 subjects. Study open to subjects with steroid-refractory or dependent chronic graft vs host disease.
Series of 6 aphereses and 28 re-infusions over 24 weeks. Primary endpoint is FFS at 24 weeks. Primary objective is to measure the efficacy of CARE (Continuous Alloreactive T-Cell depletion and Regulatory T-cell Expansion)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Newly diagnosed chronic GVHD as defined by the National Institutes of Health (NIH) Consensus with no more than 24 weeks of treatment with systemic steroids.
- •Chronic GVHD must be refractory or dependent to standard therapy, defined as (one of the following):
- •Progression on prednisone 7 mg/kg/week for 2 weeks, or
- •Stable disease on ≥ 3.5 mg/kg/week of prednisone for 4-8 weeks, or
- •Inability to taper prednisone below 3.5 mg/kg/week.
排除标准
- •1. Persistent, recurrent or late-onset acute GVHD, without signs of chronic GVHD.
- •Overlap GVHD syndrome with uncontrolled features of previously diagnosed acute GVHD.
- •Treatment with more than two systemic non-steroidal immunosuppressants within 4 weeks prior to enrollment.
- •Time from allogeneic transplantation > 2 years. OR
- •Lymphocyte count < 0.2 x 109/L on two last consecutive CBCs before inclusion
研究组 & 干预措施
Intervention
Open-label phase II study. After signing informed consent, patients will undergo 6 times an apheresis during the 6-month treatment period. These cells will be manufactured into the Rhitol and frozen in aliquots. Then re-infused.
干预措施: Autologous peripheral blood mononuclear cells ex vivo depleted for reactive T cells, using TH9402 based photodynamic therapy, in a final formulation of 10% DMSO, 30% autologous plasma in PlasmaLyte. (Other)
结局指标
主要结局
The primary endpoint is failure-free survival (FFS) at 24 weeks
时间窗: 24 weeks
次要结局
未报告次要终点
研究者
daphne brockington
Dr. Imran Ahmad
Maisonneuve-Rosemont Hospital