PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor

Recruitment & Eligibility

Inclusion Criteria

Age 18~80 years old, male or female;
Life expectancy≥6 months;
ECOG score: 0-2;
Advanced Solid Tumor were diagnosed by histology and cytology;
Enough venous channel,no other contraindications to the separation and collection of white blood cells;
Immunohistochemistry and RT-PCR technology will be used to determine the positive EGFR family (including EGFR, HER2, HER4) and EGFRVIII、IGF1R protein. At least one protein expressed in immunohistochemical tumor tissue should be no less than grade 2 or 2+ scores. The levels of protein are defined as follows: (according to cell staining) : grade 0: without staining; grade 1: 1-25%; grade 2: 26-50% and grade 3: 51-100%; (According to the intensity): negative; 1+; 2+ and 3+;
Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥60 x10*9/L, hemoglobin≥85g/L; lymphocyte ≥0.7×109/L, total bilirubin less than 2.5 times of the normal level; ALT and AST less than 2.5 times of the normal level; serum creatinine less than 1.5 times of the normal level；
Signed informed consent；
Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 4 months following the cells transfusion.
Disease progression and the current treatment is invalid.
The treatment effect is not ideal after receiving 2 line therapy at least and willing to join in clinical trials

Exclusion Criteria

Expected Overall survival < 6 months;
Patients with uncontrolled hypertension,unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months.
Abnormal lung function: FEV (forced expiratory volume) < 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) < 30% prediction, blood oxygen saturation < 90%;
Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
Uncontrolled active infection.
Serious chronic disease of critical organs such as kidney and liver. Kidney function more than CKD stage I,and liver function less than the Child - Pugh class B;
Long-term use or being used of immunosuppressive drugs with autoimmune diseases
Glucocorticoid is needed in a long term.
Currently (within 30 days) enrolled in another clinical trial.
Pregnancy or breastfeeding women.

Study & Design

Arm && Interventions

Group	Intervention	Description
HerinCAR-PD1 cells	HerinCAR-PD1 cells	Patients will receive 3 cycles of HerinCAR-PD1 cells treatment.

Primary Outcome Measures

Secondary Outcome Measures

Name	Time	Method
Quality of life	2 years	Questionnaire will be used.

Recruitment & Eligibility