NK Cell Therapy for Malignant Solid Brain Tumors

Más betegség

• Active hepatitis B or C virus, HIV infection, or other untreated active infection
• Participants with organ failure
• Participants with a chronic disease requiring immunologic or hormonal therapy
• Participants with an allergy to immunotherapy and related cells
• Participants with uncontrolled intercurrent illness
• Participants with psychiatric illness/social situations that would limit compliance with study requirements
• Participants with a history of organ transplantation or who are awaiting organ transplantation

Egyéb

• Pregnant and lactating women

• Male or female, age 18-70 years old (both ends included)
• 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
• Karnofsky Performance Status (KPS) ≥ 60%
• Life expectancy > 4 weeks, and must be able to undergo an MRI with contrast
• 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)
• Dexamethasone dose ≤ 4 mg/day or equivalent corticosteroid dose, or no dexamethasone administered
• 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
• No obvious hereditary diseases
• Normal cardiac function with left ventricular ejection fraction >55%
• No bleeding and coagulation disorders
• 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
• 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
• Signed, written informed consent