肿瘤细胞治疗研究
英文原题：Gamma Delta T-cell Infusion for AML at High Risk of Relapse After Allo HCT
这是一项 I 期注册临床试验，评估γδ T 细胞治疗急性髓系白血病的安全性、可行性及初步疗效。当前状态：进行中（不再招募）。计划入组 20 例。试验地点：美国 · 坦帕（共 1 个中心）。登记号：NCT05015426。
不限性别 · ≥ 18 Years 且 ≤ 75 Years
纳入标准： * 男性或女性，年龄18–75岁，拟接受异基因造血干细胞移植，或患ELN 2017不良风险AML并接受研究治疗。 * 移植时骨髓形态学原始细胞<5%。移植前或移植后流式细胞术/分子检测提示微小残留病（MRD）者可入组。 * 筛选期间Karnofsky体能状态评分（KPS）≥70%。 * 无有症状的充血性心力衰竭或未控制的心律失常。 * 器官功能符合方案要求。 * 血清妊娠试验阴性。 * 有生育能力的女性及男性须同意在入组前及研究治疗（T细胞输注）后至少30天采取充分避孕措施（激素或屏障避孕，或禁欲）。若女性受试者或男性受试者的女性伴侣在研究期间妊娠或怀疑妊娠，应立即告知主治医师。 * 已签署并注明日期的知情同意书。 * 表示愿意遵守所有研究程序，并能在整个研究期间参加。 * 同意在研究期间遵守生活方式要求。 排除标准： * γδ T细胞输注时因任何原因正在使用全身性糖皮质激素，以避免其抑制γδ T细胞功能。 * 活动性II–IV级急性GVHD（既往有GVHD者须在输注研究细胞产品前至少14天停用泼尼松）。 * 未控制的严重感染。 * HCT后任何时间出现白血病形态学复发。 * 活动性中枢神经系统恶性肿瘤。 * 妊娠或哺乳期。 * T细胞输注前14天内接受其他研究性药物或其他干预。
Inclusion Criteria: * Male or female, aged between 18 and 75 years of age undergoing allogeneic hematopoietic stem cell transplantation (alloHCT) or the treatment ELN 2017 adverse risk AML * Have \< 5% blasts in bone marrow by morphology at the time of transplantation. Patients with pre-alloHCT or post-alloHCT flow cytometric or molecular evidence of MRD are allowed * Karnofsky performance status (KPS) ≥ 70% during the study screening. * Free of symptomatic congestive heart failure or uncontrolled arrhythmia * Adequate organ function as defined per protocol * Negative serum pregnancy test * Note: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for at least 30 days following study treatment (T-cell infusion); should a woman subject or female partner of a male subject become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately. * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study. * Agreement to adhere to Lifestyle Considerations throughout study duration Exclusion Criteria: * Current use of concomitant systemic glucocorticoid at the time of γδ T-cell infusion for any reason will not be allowed in order to avoid their immunosuppressive effects on γδ T-cell function. * Active grade II-IV acute GVHD (patients with prior GVHD should be off prednisone for at least 14 days prior to infusion of the study cell product). * Uncontrolled serious infection. * Morphologic relapse of leukemia at any timepoint after HCT. * Active central nervous system malignancy. * Pregnancy or lactation. * Treatment with another investigational drug or other intervention within 14 days of T-cell infusion
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：Maximum Tolerated Dose · Maximum Tolerated Dose will be determined by testing increasing doses of AAPC-expanded donor γδ T-cells. · Up to 12 months；Dose Expansion: Leukemia Free Survival · Leukemia-free survival is defined as the time from the date of start of treatment to the date of relapse of AML or death from any cause · Up to 12 months
次要终点：Number of Participants with Graft Versus Host Disease (GVHD)；Overall Survival (OS)
如剂量水平1出现剂量限制性毒性（DLT），可将剂量水平-1作为降阶剂量。受试者单次输注1.0×10^6个/kg（范围0.75–1.25×10^6个/kg）的AAPC扩增供者T细胞。
受试者单次输注5.0×10^6个/kg（范围3.75–6.25×10^6个/kg）的AAPC扩增供者T细胞。
受试者单次输注2.5×10^7个/kg（范围1.875–3.125×10^7个/kg）的AAPC扩增供者T细胞。
受试者单次输注1.0×10^8个/kg（范围0.75–1.25×10^8个/kg）的AAPC扩增供者T细胞。
受试者单次输注按研究确定的最大耐受剂量给予的AAPC扩增供者T细胞。
本研究旨在确定异基因造血细胞移植（alloHCT）后单次输注人工抗原呈递细胞（AAPC）扩增的供者T细胞治疗急性髓系白血病（AML）的最大耐受剂量（MTD）和疗效。
The purposes of the study are to determine the maximum tolerated dose (MTD) and effectiveness of Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion after an allogeneic hematopoietic cell transplant (alloHCT) to treat patients with Acute Myeloid Leukemia (AML).
MEMBER ACCOUNT
登录成功会直接打开下一页。
