治疗恶性肿瘤的自体 CAR-T/TCR-T 细胞免疫疗法

计划状态

招聘

阶段

第 1 阶段/第 2 阶段

允许先接受免疫治疗

没有

CRC 指导的试验

药物

CAR-T cell immunotherapy

标签

MSI-H/ MMRd、MSS/ MMRp
地点 位置状态
中国
郑州大学第一附属医院
河南郑州 450052
招聘

联系方式

ZhongHua Yang
联系方式
18938688105 zh.yang@bindebio.com

纳入标准

纳入标准

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=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

排除标准:

ECOG >= 3
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

NCT ID

NCT03638206

添加审判日期

2018-08-20

更新日期

2019-12-11