A Phase 2 Study of the Efficacy and Safety of a Dose of Donor-Derived CD19-targeted CAR T cells for children and young adults (up to 39 years old) with recurrent or persistent CD19 (+) Acute Leukemia after Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Proportion of patients entered into complete remission (CR) within 30 days after DDCART-CD19 infusion. DDCART-CD19 product purity and Transduction Efficiency Proportion of patients maintain CR after 6 months, 1 year and 2 year after DDCAR-CD19 T-cell infusion
研究概览
简要总结
To evaluate the efficacy and safety of the infusion of DDCAR-CD19 cells. To evaluate the incidence of aGVHD and cGVHD. To determine both quantitatively and qualitatively the generation of CAR-T cells using the CliniMACS Prodigy device.
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Individuals between 6 months and 39 years of age who have recurrent or persistent CD19 (+) acute leukemia after allogeneic HSCT or following autologous CAR-T cell therapy - ≥5 X 10-4 CD19+ blast cells in bone marrow as determined per flow cytometry, or isolated extramedullary relapse. - No evidence of ≥ grade II aGVHD or chronic GVHD while off of systemic immunosuppressive therapy for at least 4 weeks. - Lansky (age < 16 years at the time of assent/consent) or Karnofsky (age ≥ 16 years at time of assent/consent) performance status ≥ 50 - Availability of the initial stem cell donor.
排除标准
- •Active severe infection Active aGVHD Grade ≥II <30% expression of CD19 on the leukemic population Presence of a CD19-negative leukemic subclone Moderate/severe chronic GVHD (NIH consensus) requiring systemic steroids Eligible for therapy with recipient-derived CAR-T cells
结局指标
主要结局
Proportion of patients entered into complete remission (CR) within 30 days after DDCART-CD19 infusion. DDCART-CD19 product purity and Transduction Efficiency Proportion of patients maintain CR after 6 months, 1 year and 2 year after DDCAR-CD19 T-cell infusion
Proportion of patients entered into complete remission (CR) within 30 days after DDCART-CD19 infusion. DDCART-CD19 product purity and Transduction Efficiency Proportion of patients maintain CR after 6 months, 1 year and 2 year after DDCAR-CD19 T-cell infusion
次要结局
- Duration of DDCART cell detection in patients' blood Duration of B-cell aplasia Correlation of DDCART cell and B-cells detection with disease relapse
研究者
Evgenios Goussetis
Scientific
Nosokomeio Paidon I Agia Sofia