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一个2期随机试验,用于新发型1型糖尿病儿童自身多克隆扩展调节性T细胞

Christine Bender¹, Alice E Wiedeman¹, Alex Hu²

¹Center for Translational Immunology, Benaroya Research Institute at Virginia Mason, Seattle, WA 98101, USA.

Science translational medicine

|May 8, 2024

概括

一次剂量扩展调节性T细胞 (Tregs) 并不能预防儿童1型糖尿病的进展. 在未来的T1D治疗中,Treg质量,而不是剂量,可能对潜在的疗效至关重要.

科学领域:

免疫学免疫学免疫学
内分泌学在内分泌学.
临床试验临床试验

背景情况:

调节性T细胞 (Tregs) 对于免疫耐受性和预防自身免疫性至关重要.
1型糖尿病 (T1D) 是一种自身免疫性疾病,其特征是破坏产生胰岛素的β细胞.
之前的第一阶段试验表明,在患有T1D的成年人中,自主Treg采用转移的安全性.

研究的目的:

探索自主多克隆扩展Tregs (expTregs) 在新发型T1D中的疗效.
评估不同剂量的expertreg对维护β细胞功能的影响.
确定影响儿科T1D患者expTreg疗效的因素.

主要方法:

一个随机,双盲,安慰剂控制的第二阶段试验 (NCT02691247),涉及110名患有新发型T1D的儿童和青少年.
参与者被随机分配到高剂量的exTregs,低剂量的exTregs或安慰剂.
分析包括细胞测量,expTregs和外周血液样本的批量和单细胞RNA测序.

主要成果:

与安慰剂相比,单次的expTreg剂量是安全的,但不能防止残留β细胞功能在一年内下降.
在高剂量组注射后观察到活性记忆Tregs的短暂增加,这表明细胞转移成功.
实验室内exTreg扩张在参与者之间有显著差异;较低的扩张和特定的基因特征与更好的C-保存相关.

结论:

一次剂量自多克隆性exTregs不会改变儿童和青少年的T1D进展.
通过体外扩张和基因表达表明的Treg质量,似乎是潜在的治疗益处的细胞剂量比细胞剂量更关键的因素.
进一步的研究应该专注于优化Treg质量,以获得有效的T1D免疫疗法.

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