NCT07021209招募中1 期
A Single-arm, Open-label, Phase I Clinical Study of GT719 Injection for Recurrent/Refractory Antibody-mediated Neurological Immune Diseases
Grit Biotechnology1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1月14日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence and severity of adversed events
研究概览
简要总结
This study is an open-label, prospective, exploratory clinical trial that includes a dose escalation phase and a dose expansion phase, aimed at evaluating the safety, cell dynamics, and preliminary efficacy of GT719 cells in adult participants with recurrent/refractory antibody-mediated neurological immune diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily enrolled in the study, signed an informed consent form, willing and able to comply with the study protocol.
- •Expected survival period>12 weeks.
- •Any previous systemic treatment must have undergone at least 4 weeks or 5 half lives (whichever is shorter) by the time the participant plans to receive the study treatment.
排除标准
- •History of organ transplantation, splenectomy, and allogeneic or autologous stem cell transplantation.
- •History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy.
- •Received systemic corticosteroids at a dose of ≥10 mg/day prednisone equivalent within 7 days prior to GT719 infusion, except for inhaled corticosteroids.
研究组 & 干预措施
GT719 Injection treatment group
Experimental
GT719 Injection
干预措施: GT719 Injection (Biological)
结局指标
主要结局
Incidence and severity of adversed events
时间窗: 24 months
To characterize the safety profile of GT719 in patients with recurrent/refractory antibody-mediated neurological immune diseases as measured by the incidence and severity of adverse events
次要结局
- Pharmacokinetics of GT719 cells(24 months)
研究者
研究点 (1)
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