brain glioma
Conditions
Interventions
A:VIT-EGFRV?-CART
Sponsors
Wuhan General Hospital of Guangzhou Command
Eligibility
Sex/Gender
All
Age
18 Years to 69 Years
Inclusion criteria
Inclusion criteria: 1. EGFRV III expression positive and histologically confirmed as brain glioma; 2. Aged between 18 and 69 years; 3. persistent cancer after at least one prior surgeryl with/without combined chemotherapy and rediotherapy, has no willing for more surgery or cannot be suitable for surgery patients; 4. tumor is too big to surgical resection; 5. life expectancy greater than 3 months; 6. satisfactory organ and bone marrow function as defined by the following: (1) creatinine 55%; (3) hemoglobin>9g/dl, bilirubin 2.0×the institution normal upper limit; 7. without bleeding disorder or coagulation disorders; 8. Dont allergy to Radiocontrast agent; 9. birth control; 10. Adequate venous access for apheresis, and no other contraindications for leukapheresis; 11. Voluntary informed consent is given.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary; 3. patients in the situation of: (1) 30 days before apheresis is still in the period of other antitumor drug observation; (2) patient dont recuperate from earlier acute adverse influence brought by any treatments accepted before; 4. Four weeks before recruit accepted radiation therapy; 5. Previously treatment with any gene therapy products; 6. Feasibility assessment during screening demonstrates<30% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation; 7. Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, grade III or IV cardiac disease, serious arrhythmia, liver and kidney disorders or metabolic diseases, CNS diseases); 8. Patients who cannot tolerate or do not cooperate with arterial intubation; 9. Patinets with severe allergy to contrast agents, and with severe acute hypersensitive reaction; 10. Patients with a marked increase in intracranial pressure; 11. patients with severe hepatic and renal dysfunction; 12. patients with abnormal hematopoietic function or blood coagulation function; 13. Taking part in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cytokines IL-1beta;cytokine IL-2R;cytokine IL-6;cytokine IL-8;cytokine IL-10;cytokine TNF-alpha;copy numbers of CART in vivo;serum CEA;tumor size; | — |
Countries
China
Contacts
Public ContactBo Diao
Wuhan General Hospital of Guangzhou Command
Outcome results
None listed