Clareo Health | Efficacy and Safety Evaluation of Percutaneous Ommaya Capsule Injection of Autologous Bi-dimensional Specific T Cells in the Treatment of Glioma and in Combination With Pemetrexed in the Treatment of Brain/Meningeal Metastases
Efficacy and Safety Evaluation of Percutaneous Ommaya Capsule Injection of Autologous Bi-dimensional Specific T Cells in the Treatment of Glioma and in Combination With Pemetrexed in the Treatment of Brain/Meningeal Metastases
1. Clear diagnosis of glioma; The pathological diagnosis of the primary lesion is clear, and the intracranial lesion can be diagnosed as intracranial metastasis by clinical, cerebrospinal fluid and imaging diagnosis according to the standards of the European Society of Neuro-Oncology - European Society of Medical Oncology (EANo-ESMO).
2. Patients with glioma and solid tumor with brain metastasis who have relapsed after surgery, whole brain radiotherapy or chemotherapy, or who are intolerant and not suitable for surgery or radiotherapy, and who are determined by clinicians to no longer benefit from systemic chemotherapy;
3. Surgical indications for Ommaya capsule implantation;
4. Age ≥18 years old and ≤80 years old, regardless of gender;
5. ECOG score for general physical condition is 0 \~ 2;
6. The expected survival time is at least 1 month;
7. WBC≥3.0×109/L, Hb≥90g/L, PLT≥75×109/L at baseline upon enrollment;
8. Liver and kidney function are basically normal A) Liver: total bilirubin ≤2.0 mg/dL (34.2umol/L), AST and ALT≤ 2.5 times the upper limit of normal value, AST and ALT≤ 5 times the upper limit of normal value in patients with liver metastasis.
B) Kidney: creatinine ≤2.5 mg/dL (221umol/L), creatinine clearance ≥60 mL/min;
9. Understand and sign informed consent to participate in clinical study voluntarily.
You may not be if
1. Patients with primary brain tumors other than glioma;
2. Patients with systemic metastasis, poor general condition, and expected survival time less than 1 month;
3. People allergic to pemetrexed;
4. Severe coagulation disorder;
5. Severe active infection and other serious complications;
6. Patients with active viral hepatitis;
7. There are urgent intracranial symptoms (cerebral hernia, etc.), systemic diseases affecting treatment, and basic diseases affecting patients' cognitive function (such as cerebrovascular diseases, Alzheimer's disease, etc.);
8. Pregnant or lactating women;
9. Within 4 weeks prior to enrollment, translumbar administration was performed;
10. Other factors considered by researchers are not suitable candidates.
