A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients With Recurrent/Progressive High-grade Glioma.

Inclusion Criteria

• •1. Age 18-70 years old (including the critical value), male or female;
• •2. Patients with high-grade glioma who have recurred/progressed after receiving standard therapy as confirmed by histopathological confirmation meeting the 2021 World Health Organization (WHO) classification criteria for central nervous system tumors;
• •3. Karnofsky Performance Score (KPS) ≥ 60 points (see Appendix 2);
• •4. Suitable for placement of Ommaya sac as judged by the investigator to be eligible for administration;
• •5. Estimated survival ≥ 3 months;
• •6. Good organ function;
• •7. Voluntary participation and ability to sign informed consent form prior to the start of study-related procedures, after explaining the content of the study;
• •8. Subjects of childbearing potential and sexually active partners must be willing to use a medically approved and effective method of contraception, such as a double-barrier method of contraception, during treatment and for 6 months after the last dose, and the male agrees not to donate sperm;
• •9. Females of childbearing potential, must have a negative blood pregnancy test result within 7 days prior to the first dose and be willing to undergo additional pregnancy tests during the study. Females of childbearing potential who have not undergone surgical sterilization (i.e., bilateral tubal ligation, bilateral oophorectomy, or total hysterectomy) or are not postmenopausal; Menopause is the absence of menopause for 12 months in women over ≥ age of 45 and the exclusion of other causes of amenorrhea. In addition, serum follicle-stimulating hormone (FSH) levels in women under 50 years of age must be in the postmenopausal range for menopause to be confirmed;
• •10. Good compliance, willing and able to follow all research procedures, and cooperate with observation and follow-up.