Autologous Immunotherapy With Multi-target Gene-modified CAR-T/TCR-T Cell for Malignancies
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0
研究概览
简要总结
This is a single arm, open-label, uni-center, phase I-II study to evaluate the safety and effectiveness of CAR-T/TCR-T cell immunotherapy in treating with different malignancies patients.
详细描述
The study is a multi-target gene-modified immunotherapy. CAR-T/TCR-T cells include ten different tumor-specific antibody.They are as following:anti-CD19 antibody for B cell leukemia and lymphoma;anti-CD22 antibody for B cell leukemia and lymphoma;anti-CD33 antibody for myeloid leukemia;anti-BCMA antibody for multiple myeloma;anti-CD38 antibody for multiple myeloma;anti-NY-ESO-1 antibody for multiple myeloma,esophagus cancer,lung cancer,melanoma and synovial sarcoma;anti-DR5 antibody for hepatoma;anti-C-met antibody for hepatoma,colorectal cancer,ovarian cancer and renal carcinoma;anti-EGFR V III antibody for hepatoma,lung cancer and glioma;anti-Mesothelin antibody for gastric cancer,pancreatic cancer and mesothelioma.
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
- 4 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •If patients had receive immunotherapy, they should reach PR/NR, or recurrency.
- •Patients must be willing to sign an informed consent.
- •age: 4 to 70 years
- •Estimated survival of ≥ 12 weeks, but ≤ 2 years
- •Blood tumor or solid tumor was diagnosed by histopathology.Positive expression of CD19, CD22, CD33, CD38, BCMA, NY-ESO-1, c-met, Mesothelin, CEGFRvIII and DR5 was confirmed by biopsy IHC test or flow cytometry test. If NY-ESO-1 is positive expression ,positive HLA-A*0201 is required at the same time .
- •Subjects with solid tumor must have measureable disease
- •Routine blood test：hemoglobin>=90 g/L; platelet>=50×10^9/L.
- •Renal function:BUN: 9-20mg / dl; serum creatinine<= 1.5 times upper limits of normal; endogenous creatinine clearance rate>=50 ml/min
- •Negative serum antibody for EBV, CMV, HIV , syphilis, HBVa nd HCV(patients with liver cancer were excluded)
- •Cardiac function: stable hemodynamic and left ventricular ejection fraction (LVEF)>=55%.
- •ECOG score ≤2
- •Adequate venous access for apheresis, and no other contraindications for leukapheresis
- •Women of child-bearing age must have evidence of negative pregnancy test.
- •Subjects of reproductive potential must agree to use acceptable birth control methods within 1 year after treatment, as described in protocol.
排除标准
- •Patients with history of T cell tumors
- •Patients with severe insufficient cardiac, pulmonary and hepatorenal functions
- •Acute or chronic GVHD after allogeneic hematopoiesis
- •steroid hormoneswere used before and after blood collection and infusion
- •HIV infection or active hepatitis B or hepatitis C infection
- •Uncontrolled active infection
- •Enrolled to other clinical study in the last 4 weeks.
- •Subjects with systemic auto-immune disease or immunodeficiency.
- •Subjects with CNS diseases.
- •Other patients that researchers considered unsuitable for inclusion
结局指标
主要结局
Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0
时间窗: 60 months
Safety evaluation
次要结局
- Clinical response(60 months)
- CAR-T cells testing(60 months)