Intervention of CAR-T Against Cervical 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 this study.

Más betegség

• History of epilepsy or other central nervous system diseases.
• history of serious cyclophosphamide toxicity.
• Serious active infection during screening.
• Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.

Laborértékek

• History of prolonged or serious heart disease during QT.
• Inadequate liver and renal function with
  • serum creatinine > 1.5 mg/dl;
  • serum (total) bilirubin > 2.0 mg/dl;
  • AST \& ALT > 3 x ULN.

Egyéb

• Airway obstruction caused by tumor.
• Pregnant or lactating females.
• Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

• Patients with stage III, IV or relapsed cervical cancer confirmed by histology and biopsy.
• Age: ≥ 18 years and ≤ 70 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.
• GD2, PSMA, Muc1, Mesothelin or other markers is expressed high (above 2+) in malignancy tissues by immuno-histochemical or flow cytometry.
• Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
• Expected survival ≥ 12 weeks.
• Initial hematopoietic reconstitution 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 ≤ 2.5×ULN.
• Oxygen saturation ≥ 90%.
• Written, informed consent obtained prior to any study-specific procedures.