Recurrent glioblasts
Conditions
Interventions
Experimental group:XYF13 CAR-T cells
Sponsors
Xi'an Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years, no gender limit; 2. Patients with recurrent glioblastoma confirmed by histology or cytology who were treated with STUPP regimen (TMZ concurrent chemoradiotherapy and adjuvant chemotherapy regimen) after surgery; 3. Have evaluable or measurable tumor lesions according to RANO criteria; 4. The clinicopathological results showed that the tumor expressed IL13 positively; 5. Adequate peripheral blood can be obtained through veins, and there are no other contraindications for lymphocyte collection; Peripheral blood cells can be collected according to the requirements of cell preparation; 6. KPS score >=70 points; 7. Estimated survival time >=3 months; 8. Patients must give informed consent to this experiment prior to the experiment and voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who received radiotherapy after recurrence; 2. Received immunosuppressant or glucocorticoid therapy within 2 weeks before enrollment; 3. Those who received live vaccine within 4 weeks prior to enrolling and/or plan to receive live vaccine after enrolling in the trial; 4. Received other chemotherapies except lymphocyte clearance within 2 weeks before enrollment; 5. Adverse events caused by previous antitumor therapy did not recover to <= grade 1 before enrollment, except hair loss and sequelae; 6. Previous cell therapy, gene therapy or other immunotherapy; 7. Past organ transplantation; 8. Patients unable to perform brain MRI examination; 9. Abnormalities of clinical significance appear in laboratory examination; 10. Acute bacterial or fungal infections requiring intravenous antibiotics during cell transfusion; 11. Negligent compensatory heart failure (NYHA grades III and IV), unstable angina pectoris, acute myocardial infarction, and persistent and clinically significant arrhythmias within 3 months prior to enrollment; 12. Patients who needed oxygen inhalation to maintain oxygen saturation above 95% before enrollment and could not return to normal within 2 weeks; 13. A history of tuberculosis; 14. Suffering from other malignant tumors that have not been effectively controlled; 15. Known or expected allergic reaction or history of allergic reaction to any of the ingredients treated in this test; 16. Known allergy to contrast media; 17. A clear history of mental disorders; 18. A history of drug abuse or use; 19. Patients who are pregnant or breastfeeding, or who plan to become pregnant during the study period; 20. Women of childbearing age and fertile men cannot use effective and adequate contraceptive methods during the period of receiving the study drug and for 3 months after the study; 21. Patients who participated in other clinical trials within 30 days prior to study enrollment; 22. The investigator judged that the patients were not suitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of dose limiting toxicity events;Objective response rate; | — |
Countries
China
Contacts
Public ContactLong Qianfa
Outcome results
None listed