EUCTR2014-000584-41-ES进行中（未招募）1 期
Phase II extension study of CaspaCIDe T cells (BPX-501) 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
- 175
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
- •1.Age < 18 years and > 1 month (< 1 month upon approval by Applicant)
- •2.Life expectancy > 10 weeks
- •3.Patients deemed clinically eligible for allogeneic stem cell transplantation.
- •4.Patients may have failed prior allograft
- •5.Patients with life-threatening hematological malignancies (high-risk ALL in 1st CR, ALL in 2nd, high-risk AML in 1st CR, AML in 2nd CR;
- •6.Non-malignant disorders deemed curable by allogeneic transplantation:
- •primary immune deficiencies,
- •severe aplastic anemia not responding to immune suppressive therapy,
- •osteopetrosis,
- •selected cases of hemoglobinopathies, for example, ß0 ß0 thalassemia major, sickle cell disease, Diamond- Blackfin
- •congenital/hereditary cytopenia, including Fanconi Anemia before any clonal malignant evolution (MDS, AML).
- •7.Lack of suitable conventional donor (HLA identical sibling or HLA phenotypically identical relative or 10/10 unrelated donor evaluated using high resolution molecular typing) or presence of rapidly progressive disease not permitting time to identify an unrelated donor
- •8.A minimum genotypic identical match of 5/10 is required.
- •9.The donor and recipient must be identical, as determined by high resolution typing, on at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLA- DRB1.
- •10.Lansky/Karnofsky score > 50
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 170
- •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
- •1.Greater than ongoing Grade II acute GvHD or chronic extensive GvHD due to a previous allograft at the time of screening
- •2.Patient receiving an immunosuppressive treatment for GvHD treatment due to a previous allograft at the time of screening
- •3.Dysfunction of liver (ALT/AST > 5 times normal value, or bilirubin > 3 times normal value), or of renal function (creatinine clearance <30ml/min/1.73m2)
- •4.Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction < 40%)
- •5.Current active infectious disease (including positive HIV serology or viral RNA)
- •6.Serious concurrent uncontrolled medical disorder
- •7.Pregnant or breast feeding female patient
研究者
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