NCT07132112招募中1 期
A Single-arm, Open-label Clinical Study of GT719 Injection for Moderate to Severe Refractory Autoimmune Disease
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10月28日最近更新:
适应症
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 of treatment-emergent adverse events
研究概览
简要总结
This study is a prospective single-arm open-label clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in patients with moderate to severe refractory autoimmune disease. A total of 30 subjects will be enrolled in this study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Voluntarily enrolled in the study, signed an informed consent form, willing and able to comply with the study protocol.
- •2. Aged 18 to 65 years (inclusive), regardless of gender.
- •Specific inclusion criteria:
- •3. Participants with systemic lupus erythematosus (SLE)
- •Meets the classification criteria for SLE in the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR);
- •Disease activity score SLEDAI-2000 ≥ 6, with at least one British Islet Lupus Assessment Group Index (BILAG-2004) Grade A (severe manifestations) or two Grade B (moderate manifestations) organ scores, or both; Or the disease activity score SLEDAI-2000 ≥ 8;
- •4. Participants with idiopathic inflammatory myopathy （IIM）
- •Complies with the 2017 EULAR/ACR classification criteria for inflammatory myopathy (including DM, PM, ASS, and NM)
- •Myositis antibody positive;
- •. Meets the definition of recurrence, refractory or progressive;
- •5. Participants with systemic sclerosis
- •. Meet the 2013 American College of Rheumatology (ACR) SSc criteria;
- •. SSc related antibodies are positive;
- •. Meets the definition of refractory or progressive recurrence
排除标准
- •1. Within 3 weeks prior to lymphodepleting chemotherapy, complement inhibition therapy (such as Ecuzumab) has been used;
- •2. Received attenuated live vaccine within 4 weeks before lymphodepleting chemotherapy;
- •3. Having undergone major surgery within the 8 weeks prior to screening, or planning to undergo surgery during the study period;
- •4. Medical history of organ transplantation;
- •5. Previously received CAR-T product therapy targeting any target (excluding GT719 therapy);
- •6. According to the investigator's judgment, the situations that hinder participants from participating in the entire trial, confound the trial results, or participate in the trial that are not in the best interests of the participants.
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 of treatment-emergent adverse events
时间窗: 2 years
Safety assessments are conducted using the NCI-CTCAE version 5.0 standards
Proportion of participants experiencing dose limiting toxicity
时间窗: 28 days
Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion
次要结局
- Efficacy outcomes for Inflammatory Myopathy(14 days; 1, 2, 3, and 6 months post GT719 infusion)
- Efficacy outcomes for SLE(14 days; 1, 2, 3 and 6 Months post GT719 infusion)
- Efficacy outcomes for Systemic Sclerosis(14 days; 1, 2, 3, and 6 months post GT719 infusion)
研究者
研究点 (1)
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