肿瘤细胞治疗研究
英文原题：Innate Donor Effector Allogeneic Lymphocyte Infusion After Stem Cell Transplantation: the IDEAL Trial
⚠ 该试验的登记信息已有 30 个月未更新， 页面上显示的「招募中」可能已经失效。联系研究中心之前，建议先到 ClinicalTrials.gov 核对登记原文的最新状态与联系方式。
这是一项 II/III 期注册临床试验，评估细胞治疗用于骨髓增生异常综合征的安全性、可行性及初步疗效。当前状态：招募中。计划入组 80 例。试验地点：欧洲 · 哥本哈根（共 1 个中心）。登记号：NCT05686538。
不限性别 · ≥ 18 Years 且 ≤ 80 Years
纳入标准：诊断为AML或MDS；年龄≥18岁；移植物类型为外周血干细胞（PBSC）；供者年龄≥18岁；供者和受者均签署知情同意书。排除标准：供者进行白细胞单采时需要中心静脉通路。
Inclusion Criteria: * Diagnoses: AML, MDS * Age: ≥18 years * Graft type: PBSC * Donor: ≥18 years * Informed consent from both donor and recipient Exclusion Criteria: • Donors with need for central venous access for the leukapheresis procedure
以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：Relapse-free survival · Relapse-free survival · 1 year from transplantation；aGVHD · Acute graft-versus-host-disease grade 2-4 · 100 days from transplantation
次要终点：iDLI dose；iDLI phenotype；Neutrophil engraftment
常规异体造血干细胞移植后第14天输注去除TCRαβ/CD19细胞的DLI。
常规异体造血干细胞移植。
异体造血干细胞移植（HSCT）的治愈原理是供者移植物细胞清除患者（受者）的恶性细胞，这一过程称为移植物抗白血病（GVL）效应。传统上GVL主要由供者αβ T细胞介导，涉及基于个体遗传差异的异体免疫反应。因此αβ T细胞也可能攻击受者正常细胞，引起危险的HSCT并发症移植物抗宿主病（GVHD），并带来发病和死亡风险。供者移植物中的其他细胞——先天效应淋巴细胞——也可参与GVL，包括自然杀伤（NK）细胞和T细胞受体（TCR）γδ细胞（后者为T细胞亚群）。NK和TCR γδ细胞可直接识别并清除白血病细胞，不依赖传统异体免疫反应，因此可能在介导GVL的同时较少引起GVHD。成人接受HSCT的主要适应症为急性髓系白血病（AML）和骨髓增生异常综合征（MDS）；约50%的AML/MDS移植患者发生显著急性GVHD，约30%发生恶性疾病复发。研究团队既往前瞻性研究显示，移植物中及HSCT后早期免疫重建期间先天淋巴细胞数量较高的患者，GVHD和复发风险均较低。因此，本试验拟在HSCT后早期为患者输注富集NK和TCR γδ细胞、去除αβ T细胞的先天免疫供者淋巴细胞（iDLI），以减少GVHD和复发，改善AML/MDS患者的生存和生活质量。
The curative principle behind allogeneic hematopoietic stem cell transplantation (HSCT) is eradication of the malignant cells of the patient (recipient) by donor graft cells, a process termed graft-versus-leukemia (GVL) effect. GVL is traditionally mediated by donor αβ T cells in an immunological process driven by genetical differences between individuals, i.e. an allogeneic response. For this reason, αβ T cells also cause an unwanted and dangerous complication of HSCT called graft-versus-host disease (GVHD) in which healthy recipient cells are targeted by donor cells with great risk of morbidity and mortality to the patient. In addition to αβ T cells, other cells from the donor stem cell graft, termed innate effector lymphocytes, can contribute to the GVL effect. These are termed natural killer (NK) cells and T-cell receptor (TCR) γδ cells, the latter being a subset of T cells. NK and TCR γδ cells can recognize and eliminate leukemic cells in a direct tumor response independent of conventional allogeneicity. Therefore, opposite αβ T cells, innate effector lymphocytes cells can mediate GVL but are not likely to cause GVHD. The main indications for HSCT in adults are acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Approximately 50% of AML/MDS transplant patients experience significant acute GVHD and 30% experience relapse of the malignant disease. Prospective clinical studies from the research group of the investigators have shown that patients with high doses of innate lymphocytes in stem cell grafts and during early immune reconstitution after HSCT have a reduced risk of both GVHD and relapse. The aim of this clinical trial is therefore to administer innate donor lymphocyte infusion (iDLI) enriched in NK and TCR γδ cells and depleted of αβ T cells in patients early after HSCT. By improving the HSCT procedure with iDLI cell therapy the scope is less GVHD and less relapse of the malignant disease and thereby improved survival and life quality in AML/MDS patients.
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