NCT07142161进行中（未招募）1 期
A Study on the Safety, Preliminary Efficacy, and Cellular Kinetics of Allogeneic CD7-targeted CAR-T Cell Injection in the Treatment of Type 1 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- The incidence of dose-limiting toxicity (DLT) of RD13-02 in patients with type 1 diabetes, as well as the incidence of adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI)
研究概览
简要总结
This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD13-02 in patients with aT1DM
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 diabetes presenting with any of the following conditions:
- •Impaired hypoglycemia awareness (lack of sufficient autonomic symptoms when plasma glucose is below 54 mg/dL [3 mmol/L]) or other clinically diagnosed neuropathy caused by type 1 diabetes, including but not limited to gastrointestinal autonomic neuropathy Metabolic instability: two or more previous severe hypoglycemic events that required assistance from others, or two or more hospitalizations for ketoacidosis in the past year
- •Age ≤ 60 years
- •Body weight ≥ 40 kg
- •At least one positive islet autoantibody, including glutamic acid decarboxylase autoantibody (GADA), protein tyrosine phosphatase autoantibody (IA-2A), insulin autoantibody (IAA) (only applicable within 2 weeks of insulin treatment), zinc transporter 8 antibody (ZnT8), islet cell autoantibody (ICA), etc.
- •MMTT stimulated C-peptide peak > 0.1 nmol/L, or fasting C-peptide > 0.05 nmol/L
- •Female subjects of childbearing potential must have a negative serum or urine pregnancy test at screening
- •Both male and female subjects must be willing to use contraception from the time of signing the informed consent form until 12 months after cell infusion
- •The subject or their legal guardian voluntarily participates in this study and is able to sign the informed consent form
排除标准
- •If any of the following criteria are met, the subject will be excluded from the study.
- •Type 2 diabetes, or diabetes mellitus from pregnancy, single-gene mutation, pancreatic injury, or other secondary causes (e.g., Cushing's syndrome, thyroid dysfunction, or acromegaly)
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 x ULN, or total bilirubin ≥ 1.5 x ULN
- •Severe heart disease, with any of the following:
- •Myocardial infarction within 1 year before enrollment
- •Signs or symptoms of heart failure of NYHA Class ≥ 3 within 1 year before enrollment
- •Left ventricular ejection fraction (LVEF) < 50% at screening
- •QTcF > 450 msec (males) or > 470 msec (females), based on the QTcF value from a single ECG or the average of three repeated ECGs taken more than 3 minutes apart (QT interval corrected by Fridericia's formula)
- •Severe concurrent diabetic nephropathy, with an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2
- •Currently undergoing or expected to require renal replacement therapy during the study
- •At screening, a subject tests positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B e-antigen (HBeAg); a subject tests positive for hepatitis B e-antibody (HBeAb) with a peripheral blood HBV DNA level above the upper limit of normal; a subject tests positive for hepatitis C virus (HCV) antibody; a subject tests positive for human immunodeficiency virus (HIV) antibody; a subject tests positive for syphilis antibody; a subject tests positive for EBER or has an EBV viral load greater than the upper limit of normal
- •Participated in another clinical study within 3 months prior to enrollment
- •Received a live attenuated vaccine within 4 weeks prior to enrollment
- •The investigator considers the patient to have latent T1DM, including latent autoimmune diabetes in adults (LADA) and latent autoimmune diabetes in the young (LADY)
- •The investigator believes there are other reasons that make the subject unsuitable for this clinical study
研究组 & 干预措施
RD13-02
Experimental
CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphami
干预措施: RD13-02 cell infusion (Drug)
结局指标
主要结局
The incidence of dose-limiting toxicity (DLT) of RD13-02 in patients with type 1 diabetes, as well as the incidence of adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI)
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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