Antigen-specific T Cells Against Lung Cancer

Korábbi kezelés

• Patients who require systemic corticosteroid or other immunosuppressive therapy.
• Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in any immune cell therapy study.
  • Inadequate liver and renal function with

Más betegség

• History of epilepsy or other central nervous system diseases.
• history of serious cyclophosphamide toxicity.

Laborértékek

• History of prolonged or serious heart disease during QT.
• serum creatinine > 2.5 mg/dl;
• serum (total) bilirubin > 2.0 mg/dl;
• AST \& ALT > 3 x ULN.
  • Pregnant or lactating females. 9. Serious active infection during screening. 10. Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.
  • Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

Egyéb

• Airway obstruction caused by tumor.

• Patients with stage III, IV or relapsed lung cancer confirmed by histology and biopsy.
• Age: ≥ 18 years and ≤ 80 years.
• 4 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy.
• Side Effects of Chemotherapy have subsided.
• Cancer specific antigens are identified and shown to express at high levels (>2+) in malignant tissues by immuno-histochemical staining or flow cytometry.
• Karnofsky/Lansky ≥ 50%.
• Expected survival ≥ 6 weeks.
  • Initial hematopoietic conditions with
• neutrophils (ANC) ≥ 1×10\^6/L;
• platelet (PLT) ≥ 1×10\^8/L.
  • Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with
• serum creatinine ≤ 2×ULN;
• serum bilirubin ≤ 3×ULN;
• AST/ALT ≤ 5×ULN.
  • Oxygen saturation ≥ 90%. 11. Written, informed consent obtained prior to any study-specific procedures.