A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SNC109 in Patients With Recurrent Glioblastoma
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of treatment related adverse events
研究概览
简要总结
A phase I study to evaluate the safety, tolerance and pharmacokinetics of SNC109 in patients with rGBM
详细描述
It is planned to recruit about 50 patients with rGBM subjects. The protocol consists of screening period, Lymphocytes apheresis period, Operation period, pre-infusion evaluation (-2~-1 days), infusion (day 0), infusion observation (day 1-post infusion), and follow-up period (last infusion-720 days). The incidence of dose limitation toxicity (DLT) will be observed within 28 days after the first infusion. Subjects in this study will receive multiple infusions, starting with 5×104 CAR+ T cells/dose in the first subject, and the Safety Review Committee (SRC) will evaluate the subsequent dosing regimen, dose, infusion interval, and number of treatment cycles. Subsequent subjects will be evaluated by the SRC on the basis of available PK and safety data, and the SRC will determine the dosing regimen, dose, infusion interval and number of treatment cycles based on observed evidences.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18，both sexes;
- •Diagnosed with a history of glioblastoma, and the recurrent glioblastoma has confirmed by histological/molecular pathology (including astrocytoma World Health Organization (WHO) Grade 4);
- •Karnofsky (KPS) ≥50;
- •The estimated survival time is ≥12 weeks;
- •Blood pregnancy tests for women of childbearing age are negative;
- •The patient himself/herself, and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form.
排除标准
- •Known allergies to study drugs or drugs that may be used in the study;
- •Severe concurrent diseases in the heart, lungs, liver, or other vital organs;
- •Hypertension is poorly controlled or accompanied by hypertensive crisis or hypertensive encephalopathy;
- •In addition to the glioblastoma, with other severe central nervous system diseases or complications or aggressive malignancies;
- •Long-term use of immunosuppressant drugs, or large doses of steroids;
- •Received live or attenuated vaccine or other surgery had no related to GBM within 4 weeks prior to Lymphocytes apheresis;
- •Lymphocytes apheresis or cell infusion combined with infection or unexplained fever.
研究组 & 干预措施
SNC109 CART
After the screening and evaluation, SNC-109 CAR-T Cells will be infusion.
干预措施: SNC109 (Drug)
结局指标
主要结局
Incidence of treatment related adverse events
时间窗: Up to 28 days after first infusion
Incidence of adverse events associated with CAR-T cell transfusion within 28 days of the first infusion, abnormal and clinical significant laboratory results
DLT
时间窗: Up to 28 days after first infusion
Incidence of DLT associated with CAR-T cell transfusion within 28 days of the first infusion
次要结局
- Overall survival (OS) after infusion(within 2 years after first infusion)
- Time maximum of SNC-109 Cell count and CAR vector copy number(within 2 years after first infusion)
- Pharmacokinetic (PK) profile/parameters Peak Plasma Concentration (Cmax) of SNC-109 Cell count and CAR vector copy number(within 2 years after first infusion)
- Pharmacokinetic (PK) profile/parameters Area under the plasma concentration versus time curve (AUC)(within 2 years after first infusion)
- Progression free survival (PFS) after infusion(within 2 years after first infusion)
- Efficacy assesment for the treatment according to iRANO(within 2 years after first infusion)
- Pharmacodynamic (PD) profile/parameters Changes of Cytokines after infusion(within 2 years after first infusion)
- Concentration of Human anti-chimeric antibody (HACA)(within 2 years after first infusion)