ISRCTN11859866进行中（未招募）Unknown
Memory T cells to improve immunity after TCRaß/CD19 depleted haploidentical donor stem cell transplantation for inborn errors of immunity
ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 90 人开始时间: 2023年10月25日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age at least 1 month and up to 18 years at the time of scheduled transplant
- •2. Patients deemed clinically eligible for allogeneic HSCT for non-SCID IEI
- •3. No suitable conventional matched family donor#.
- •4. Patient has an eligible donor identified by the clinical transplant team:
- •4.1. Planned mismatched family or mismatched unrelated donor for TCRaß-HaploSCT (Intervention and control group 1)*
- •4.2. 10/10 HLA-matched unrelated donor for MUD HSCT (control group 2)
- •5. Capacity for patient or the patient’s parent or guardian to provide written informed consent
- •1. # Donor choice is independent of this study and will be decided by the clinical team according to best clinical practice. Generally the hierarchy of preferred donor is 10/10 matched family donor > 10/10 matched unrelated donor > mismatched family donor > mismatched unrelated donor. However, depending on the specific disorder, a family member might not be a suitable donor if they are a carrier of the genetic disease, or the underlying molecular defect is unknown.
排除标准
- •1. Lansky/Karnofsky performance score <30%
- •2. Ongoing active acute GvHD or chronic extensive GvHD due to previous allograft at the time of screening
- •3. Patient receiving an immunosuppressive treatment for GvHD due to previous allograft at time of screening
- •4. Presence of a medical condition indicating that survival will be dismal such as the requirement for a high setting of mechanical ventilation and severe failure of a major organ system
- •5. Pregnancy or breastfeeding in female patients
- •Additional exclusion criteria for intervention group and control group 1 only (TCRaß-HaploSCT)
- •1. Patients with donor-specific antibodies (DSA) against the potential stem cell donor using the standard test according to the institutional guideline
研究者
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