NCT04717999Unknown不适用
Pilot Study of UWNKG2D CAR-T in Treating Patients With Recurrent Glioblastoma
UWELL Biopharma0 个研究点目标入组 20 人开始时间: 2021年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- Number of Participants who experience a Dose-Limiting Toxicity (DLT)
研究概览
简要总结
This is a pilot phase I study to evaluate the safety and efficacy of NKG2D CAR-T cell therapy in patients with relapsed and/or refractory glioblastoma
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed glioblastoma multiforme (GBM) and are at first or second relapse.
- •Hemoglobin ≥ 9.0 g/dl, absolute neutrophil count (ANC) ≥ 1,000 cells/µl, platelets ≥ 125,000 cells/µl
- •No active infection of HIV, HTLV and Syphilis
- •Adequate renal function
- •Adequate hepatic function
- •Adequate cardiac function
- •Adequate venous access for apheresis, and no other contraindications for leukapheresis
- •Voluntary informed consent is given.
排除标准
- •Pregnant or lactating women.
- •Uncontrolled active infection.
- •History of hepatitis B or hepatitis C infection.
- •Previously treatment with any gene therapy products or cell therapy product in past 28 days.
- •Cannot undergo MRI with contrast or SPECT/CT
- •HIV infection.
- •Have autoimmune disorders
- •Have active infection or inflammatory disorders
- •Prescreening test results in expansion rate less than 5 folds
- •An allergy to gentamycin and/or streptomycin
结局指标
主要结局
Number of Participants who experience a Dose-Limiting Toxicity (DLT)
时间窗: 2 years
Defined as the dose safely administered Intratumoral for the treatment of patients with GBM
次要结局
- Overall Response Rate(1 year)
- Progression-free survival(1 year)
研究者
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