Glioma
Conditions
Interventions
High-dose group:Infusion 2.0×10^6 UCAR+ T Cells/kg
Medium dose group:Infusion 1.0×10^6 UCAR+ T Cells/kg
Low-dose group:Infusion 0.5×10^6 UCAR+ T Cells/kg
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, no gender limit, the expected survival period is not less than 3 months; 2. Patients with advanced, locally advanced or recurrent and metastatic tumors confirmed by histology or cytology; 3. Patients who failed standard treatment in the past; or patients who gave up treatment for various reasons after first-line treatment failed; 4. Those who are ineffective in receiving PD-1 or PD-L1 antibody therapy or who have been discontinued for more than 4 weeks can be enrolled; 5. At least 1 measurable target lesion (RECIST v1.1); 6. ECOG performance status score is 0-2 points; 7. Provide primary or recurrent tumor tissue blocks and cut out at least 8 sections for staining and detection. 8. Routine blood test: white blood cell count (WBC) >= 3x10^9/L, lymphocyte percentage (LY%) >= 15%, hemoglobin Hbo (Hb) >= 90g/L, platelet (PLT) >= 60x10^9/L; 9. Liver and kidney function: alanine aminotransferase, aspartate aminotransferase (ALT, AST) 50%; 11. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with follow-up visits; 12. Patients who receive radiotherapy and chemotherapy with an interval of more than 4 weeks can be enrolled.
Exclusion criteria
Exclusion criteria: 1. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and whose peripheral blood HBV DNA titer is >=5x10^2 copies/L; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; CMV DNA positive; syphilis positive. 2. Subjects who have received any gene therapy before. 3. Long-term use of immunosuppressants for any reason. 4. Any severe, 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. 5. Subjects with severe cardiac, pulmonary, hepatic, and renal insufficiency or severe debilitating pulmonary disease; cardiac function: according to the New York Heart Association (NYHA) standard of grade three or above; liver function: Child-Puge grading standard C or above; renal function: chronic kidney disease (CKD) stage 4 or above; renal insufficiency stage ? or above; pulmonary function: symptoms of severe respiratory failure involving other organs; brain function: abnormal central nervous system or disturbance of consciousness. 6. Current systemic use of steroids (except for recent or current use of inhaled steroids). 7. Pregnant and lactating subjects (the safety of this therapy for unborn children is unclear, female research participants of reproductive potential must have a negative serum or urine pregnancy test within 48 hours before injection ). 8. Hypersensitivity to immunotherapy and related drugs. 9. Combined with a second tumor. 10. Subjects with a history of organ transplantation or waiting for organ transplantation. 11. After evaluation, the investigator believes that the subject is unable or unwilling to comply with the requirements of the research protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics; | — |
Countries
China
Contacts
Public ContactHuang Yulun
the First Affiliated Hospital of Soochow University
Outcome results
None listed