Brain glioma
Conditions
Interventions
Case series:IL-13R alpha 2 CAR-T therapy
Sponsors
The First Affiliated Hospital of Suzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. aged 18-70 years old male and female, the estimated survival time >3 months; 2. With one more lesions be able to evaluation, which was confirmed by previous biopsy or histopathology as high grade glioma (WHO grade 3 or 4). After comprehensive treatment, imaging examination indicated that the tumor continued to progress or recur; 3. The excised pathological tissue can be used for immunohistochemical detection of the target protein (paraffin section should be within half a year), and the positive expression of the target protein in accordance with pathological diagnosis (immunohistochemical staining or +++); 4. There was no contraindication of lymphocyte collection; 5. Routine blood examination: WBC >=3x10^9/L, ly 0.8x10^9/L, Hb >=90g/L, PLT >=80x10^9/L; 6. Liver and kidney functions: alanine aminotransferase, aspartate aminotransferase (alt, AST) < 3 times of normal value, total bilirubin (TBIL) < 1.5 times of normal value, serum creatinine (SCR) < 2 times of normal value; 7. The subjects voluntarily joined the study, signed the informed consent, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Active hepatitis B or C virus, HIV infection, or other untreated active infections; 2. Patients with second tumor; 3. Patients who had previously received car-t cell therapy, PD-1 antibody therapy and PD-L1 antibody therapy; 4. Long term use of immunosuppressant for any reason; 5. Any serious and 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 temporal arteritis, etc; 6. Severe heart, lung, liver and kidney insufficiency subjects or serious lung diseases; heart function: Level 3 or above according to NYHA standard; liver function: Level C or above according to child Puge standard; kidney function: above stage 4 of chronic kidney disease (CKD); above stage III of renal insufficiency; lung function: severe respiratory failure symptoms, involving other organs; brain function Ability: central nervous system abnormality or consciousness disorder; 7. Currently, steroid cells are being used in the whole body (except for those who use inhaled steroids recently or currently); 8. Pregnant and lactating subjects (the safety of this treatment for unborn children is not clear, and female study participants with reproductive potential must have negative serum or urine pregnancy test within 48 hours before injection); 9. Allergic to immunotherapy and related cells; 10. Subjects with a history of organ transplantation or waiting for organ transplantation; 11. After evaluation, the researcher believed that the subjects could not or were unwilling to comply with the requirements of the research program.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;Count of CAR-T;Response evaluation of solid tumor; | — |
Countries
China
Contacts
Public ContactYulun Huang
188 Shizi Street, Suzhou, Jiangsu, China
Outcome results
None listed