brain glioma
Conditions
Interventions
Case series:EGFRvIII CAR-T cell therapy
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Age 18 to 65 years old, male and female, pre-survival period is more than 3 months; 2) Previous biopsy or histopathology confirmed high-grade glioma (WHO grade 3 or 4). After comprehensive treatment, imaging examination suggested continued progression or recurrence; 3) Surgical resection of the pathological tissue can be used for immunohistochemical detection of EGFRvIII, and consistent with pathological diagnosis of EGFRvIII positive expression (immunohistochemical staining ++ or +++); 4) For patients taking dexamethasone, the dose must be no more than 4 mg/day 5 days before blood collection; 5) Sufficient venous access for blood sampling and venous blood sampling, no contraindications for lymphocyte collection; 6) routine blood test: white blood cell count (WBC) = 3 × 10^9 / L, lymphocyte percentage (LY%) = 15%, hemoglobin Hbo (Hb) = 90g / L, platelets (PLT) = 60 × 10^9 / L; 7) Liver and kidney function: alanine aminotransferase, aspartate aminotransferase (ALT, AST) < 3 times of normal limit, total bilirubin (TBiL) < 1.5 times of normal limit, serum creatinine (SCr) < 1.5 times of normal limit; 8) Subjects voluntarily joined the study, signed informed consent, and were well-adhered to follow-up.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1) active hepatitis B or hepatitis C virus, HIV infection, or other untreated active infections; 2) Patients who have previously received any gene therapy; 3) Long-term use of immunosuppressive agents for any reason; 4) Any serious, uncontrolled systemic autoimmune disease or any unstable systemic disease including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease and Arteritis, etc.; 5) Subjects with severe heart, lung, liver, and renal insufficiency or severe debilitating lung disease; cardiac function: Grade 3 or above according to the New York Heart Association (NYHA) criteria; Liver function: Grade C or above according to Child-Puge classification criteria; renal function: chronic kidney disease (CKD) 4 or more; renal dysfunction III or more; pulmonary function: severe respiratory failure symptoms, involving other organs; brain function: central nervous system abnormalities or disturbance of consciousness; 6) Currently using steroid drugs systemically (except for those who have recently used or are using inhaled steroids); 7) Pregnancy or lactation subjects (the safety of this therapy is unclear for unborn children, and female study participants with reproductive potential must have a negative serum or urine pregnancy tests 48 hours prior to injection. ); 8) Allergic to immunotherapy and related drugs; 9) subjects with a history of organ transplantation or waiting for an organ transplant; 10) The investigator assessed that the subject was unable or unwilling to comply with the requirements of the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events;response evaluation of solid tumor; | — |
Secondary
| Measure | Time frame |
|---|---|
| count of CAR-T; | — |
Countries
China
Contacts
Public ContactUulun Huang
The First Affiliated Hospital of Soochow University
Outcome results
None listed