EUCTR2014-000584-41-IT进行中（未招募）1 期
Phase I/II study of CaspaCide T cells from an HLA-partially matched family donor after negative selection of TCR aß+ T cells in pediatric patients affected by hematological disorders - CaspaCide TCR aß haplo HSCT
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Males or females;Age < 21 years and > 3 months; Life expectancy > 10 weeks;
- •Deemed eligible for allogeneic stem cell transplantation; Children with life-threatening hematological malignancies (high-risk ALL in 1st CR,ALL in 2nd or subsequent CR, high-risk AML in 1st CR, AML in 2nd or subsequentCR,myelodysplastic syndromes, non-Hodgkin lymphomas in 2nd or subsequent CR);Non-malignant disorders amenable to be cured by an allograft:
- •a. primary immune deficiencies,b. severe aplastic anemia not responding to immune suppressive therapy,c. osteopetrosis,d. selected cases of hemoglobinopathies ande. congenital/hereditary cytopenia, including Fanconi Anemia before any clonalmalignant evolution (MDS, AML);Lack of suitable conventional donor (HLA identical sibling or HLA phenotipically identical relative or 9-10/10 unrelated donor evaluated using high resolution molecular typing) or presence of rapidly progressive disease not permitting time to identify an unrelated donor; A minimum genotypic identical match of 5 / 1 0 is required.
- •The donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLADRB1;Lansky/Karnofsky score > 50, WHO > 4;Signed written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Age < 3 months or >21 years;Greater than grade II acute GvHD or chronic extensive GvHD due to a previous allograft at the time of inclusion; Patient receiving an immunosuppressive treatment for GvHD treatment at the time of
- •inclusion;Dysfunction of liver (ALT/AST > 5 times normal value, or bilirubin > 3 times normal value), or of renal function (creatinine clearance < 30 ml / min); Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction <40%); Current active infectious disease (including positive HIV serology or viral RNA);Serious concurrent uncontrolled medical disorder;Pregnant or breast feeding female patient; Lack of parents’ informed consent. Patients who have received more than 1 x 105 ??T cells/Kg with the graft infusion will be excluded.
研究者
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