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 receivingstandard therapy as confirmed by histopathological confirmation meeting the 2021World Health Organization (WHO) classification criteria for central nervous systemtumors;

3. Karnofsky Performance Score (KPS) ≥ 60 points (see Appendix 2);

4. Suitable for placement of Ommaya sac as judged by the investigator to be eligiblefor administration;

5. Estimated survival ≥ 3 months;

6. Good organ function;

7. Voluntary participation and ability to sign informed consent form prior to the startof study-related procedures, after explaining the content of the study;

8. Subjects of childbearing potential and sexually active partners must be willing touse a medically approved and effective method of contraception, such as adouble-barrier method of contraception, during treatment and for 6 months after thelast dose, and the male agrees not to donate sperm;

9. Females of childbearing potential, must have a negative blood pregnancy test resultwithin 7 days prior to the first dose and be willing to undergo additional pregnancytests during the study. Females of childbearing potential who have not undergonesurgical sterilization (i.e., bilateral tubal ligation, bilateral oophorectomy, ortotal hysterectomy) or are not postmenopausal; Menopause is the absence of menopausefor 12 months in women over ≥ age of 45 and the exclusion of other causes ofamenorrhea. In addition, serum follicle-stimulating hormone (FSH) levels in womenunder 50 years of age must be in the postmenopausal range for menopause to beconfirmed;

10. Good compliance, willing and able to follow all research procedures, and cooperatewith observation and follow-up.

Exclusion Criteria:

1. Received anti-tumor drug therapy such as radiotherapy, chemotherapy, biologicaltherapy, endocrine therapy, targeted therapy and other anti-tumor drugs within 4weeks before the first dose (excluding immunotherapy, nitrosourea, mitomycin C, oralfluorouracil, small molecule targeted drugs, and traditional Chinese medicines withanti-tumor indications);

2. Treatment with any other unmarketed investigational drug within 4 weeks prior to thefirst dose;

3. Surgical surgery of major organs within 4 weeks prior to the first dose (excludinglive puncture) or have had significant trauma, or need to undergo elective surgeryduring the study;

4. Those who have a history of cell therapy, gene therapy, and oncolytic virus therapyin the past;

5. Those who have known or suspected hypersensitivity to the active ingredients of thestudy drug, excipients, and imaging contrast agents;

6. Those who have a history of organ transplantation or plan to undergo organtransplantation during the study;

7. Patients with active infection or uncontrollable infection requiring intravenoussystemic therapy, or fever of unknown cause > 38.5°C during the screening period andbefore the first dose;

8. Accompanied by severe coagulation disorder or other evidence of obvious bleedingrisk; history of gastrointestinal bleeding; Any other ≥ CTCAE grade 2 bleeding eventwithin the past 6 months;

9. Patients with herniation syndrome;

10. Pregnant or lactating females.