NK Cell Therapy for Malignant Solid Brain Tumors

Inclusion Criteria

• •1. Male or female, age 18-70 years old (both ends included)
• •2. At least one evaluable lesion with previous biopsy or pathohistologic confirmation of malignant central nervous system tumor, with imaging suggestive of continued progression or recurrence after comprehensive treatment
• •3. Karnofsky Performance Status (KPS) ≥ 60%
• •4. Life expectancy \> 4 weeks, and must be able to undergo an MRI with contrast
• •5. Patients who completed radiotherapy or systemic therapies (including temozolomide/bevacizumab or other agents) for at least 4 weeks prior to enrollment. All prior treatment-related toxicities should be defined as ≤ grade 1 (except for toxicities such as alopecia or leukoplakia) according to the Common Terminology Standard for Adverse Events (CTCAE 6.0)
• •6. Dexamethasone dose ≤ 4 mg/day or equivalent corticosteroid dose, or no dexamethasone administered
• •7. Must have adequate organ and marrow function as defined below:
• •* White blood cell count (WBC) ≥ 3 x 10\^9/L
• •* Absolute neutrophil count (ANC) \> 1 x 10\^9/L
• •* Hemoglobin (Hb) ≥ 90 g/L
• •* Platelet (PLT) ≥ 80×10\^9/L
• •* Albumin transaminase (ALT) \& albumin transaminase (AST) \< 1.5 × institutional upper limit of normal (ULN)
• •* Serum creatinine (Cr) \< 1.5 x institutional ULN
• •* Total bilirubin \< 1.5 x institutional ULN
• •* PT \& PTT ≤ 1.25 x institutional ULN
• •8. No obvious hereditary diseases
• •9. Normal cardiac function with left ventricular ejection fraction \>55%
• •10. No bleeding and coagulation disorders
• •11. Absence of positive blood cultures for bacteria, fungus, or virus within 48-hours prior to NK cell infusion and/or there aren't any indications of meningitis
• •12. Fertile women must have had a pregnancy test with a negative result within 7 days prior to the start of treatment, and subjects are willing to use contraception (hormonal or barrier method of birth control or abstinence) during the clinical trial and for 6 months after the last cell infusion; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
• •13. Signed, written informed consent