NCT05528341招募中1 期
Clinical Investigation of NKG2D-CAR-NK92 Chimeric Antigen Receptor Modified NK92 Cells in the Treatment of Relapsed/Refractory Solid Tumors
Xinxiang medical university1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年1月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
The purpose of this clinical investigation is to evaluate the safety and effects of NKG2D-CAR-NK92 infusions in the treatment of relapsed/refractory solid tumors.
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
- •Age: ≥ 18 years old and ≤ 75 years old, male or female.
- •Histopathology confirmed the diagnosis of malignant tumors (including breast cancer, lung cancer, gastric cancer, ovarian cancer, cervical cancer, renal carcinoma, malignant melanoma, osteosarcoma and lymphoma).
- •Expected survival time ≥3 months.
- •Disease must be measurable according to the corresponding guidelines.
- •Fail or unwilling to receive third-line treatment.
- •The last cytotoxic drug, radiotherapy or surgery≧4 weeks.
- •HB≧90g/L, ANC≧1.5×10^9/L, PLT≧80×10^9/L, TBIL≦1.5×upper limit of normal, ALT/AST≦2.5×upper limit of normal, ALT/AST≦5×upper limit of normal if have liver metastasis, Cr≦1.5×upper limit of normal or CCr≧60ml/min.
- •Women of childbearing age must be tested negative for pregnancy within 7 days, and subjects of childbearing age must use appropriate contraception during both the trial and for 3 months after the test;
- •Written informed consent form must be signed before enrollment.
- •Patient with MICA/B+ cell tumors confirmed by pathology and histology.
排除标准
- •The patient has other malignancies or has been diagnosed with other malignancies within the last 5 years (except clinically cured carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, and thyroid papillary carcinoma).
- •Patients with brain metastases with symptoms or with symptom control for less than 3 months.
- •Active autoimmune disease.
- •Severe autoimmune diseases or congenital immunodeficiency.
- •Concomitant serious infection or other serious underlying medical condition.
- •Active hepatitis patients (including hepatitis B and C).
- •History of severe immediate hypersensitivity to any of the biological products including penicillin.
- •Drug abuse, medical, psychological or social conditions that may interfere with a subject's participation in the study or evaluation of the results of the study.
- •Simultaneous participation in another clinical trial within 4 weeks.
- •Cell therapy or gene therapy in the previous 1 month.
- •A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation.
- •Investigator considers that the subject has any clinical or laboratory abnormalities or compliance problems and is not suitable to participate in this clinical study.
研究组 & 干预措施
NKG2D-CAR-NK92 cells immunotherapy
Experimental
Preparation of NKG2D-CAR-NK92 cells suspended in saline solution.
干预措施: NKG2D-CAR-NK92 cells (Biological)
结局指标
主要结局
Objective Response Rate
时间窗: up to one year
Solid tumors to NKG2D-CAR-NK92 cells infusions
Number of participants with adverse events evaluated with CTCAE, version 4.0
时间窗: 3 months
Safety evaluation
次要结局
- Quality of Life Score(up to one year)
- Disease Control Rate(up to one year)
- Overall Survival(up to one year)
- Progression-free Survival(up to one year)
研究者
研究点 (1)
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