Advanced glioma
Conditions
Interventions
Low dose group:Infusion of low-dose UCAR+ T Cells/kg
Medium dose group:Infusion medium dose UCAR+ T Cells/kg
High dose group:Infusion of high-dose UCAR+ T Cells/kg
Sponsors
Zhongshan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-70 years old, both male and female, the pre-survival period is not less than 3 months; 2. Patients with relapsed or refractory high-grade glioma 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 treatment or who have been discontinued for more than 4 weeks can be enrolled 5. At least one measurable target lesion (RANO 2010 version standard); 6. ECOG performance status score of 0-2; 7. Provide primary or recurrent tumor tissue blocks and cut out at least 10 sections for staining and detection; 8. Routine blood test: white blood cell count (WBC) >=3*10^9/L, lymphocyte percentage (LY%) >=15%, hemoglobin Hbo (Hb) >90g/L, platelet (PLT) >=60*10^9/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 the follow-up; 12. Patients who received radiotherapy and chemotherapy with an interval of more than 4 weeks can be enrolled.
Exclusion criteria
Exclusion criteria: 1. Subjects with hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer detection >=5*10^2 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. Patients 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 heart, lung, liver, and renal insufficiency or severe debilitating lung disease; heart function: according to the New York Heart Association (NYHA) standard of grade three or above; liver function: Child-Puge classification standard is Grade 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 study participants of reproductive potential must have a negative serum or urine pregnancy test within 48 hours before injection ); 8. Allergy 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 |
|---|---|
| MR;Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival, PFS; | — |
Countries
China
Contacts
Public ContactLei Feng
Zhongshan People's Hospital
Outcome results
None listed