Antigen-specific T Cells Against Lung Cancer
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring Lung cancer, CAR-T, mesothelin, Muc1, GD2, MAGE-A4
Eligibility Criteria
Inclusion Criteria:
- 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.
10. Oxygen saturation ≥ 90%. 11. Written, informed consent obtained prior to any study-specific procedures.
Exclusion Criteria:
- Airway obstruction caused by tumor.
- History of epilepsy or other central nervous system diseases.
- Patients who require systemic corticosteroid or other immunosuppressive therapy.
- History of prolonged or serious heart disease during QT.
- history of serious cyclophosphamide toxicity.
- 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
- serum creatinine > 2.5 mg/dl;
- serum (total) bilirubin > 2.0 mg/dl;
AST & ALT > 3 x ULN.
8. 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.
11. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
Sites / Locations
- Jinshazhou Hospital of Guangzhou University of Chinese MedicineRecruiting
- Shenzhen Geno-immune Medical InstituteRecruiting
- Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer CenterRecruiting
Arms of the Study
Arm 1
Experimental
Lung cancer-specific T cells
Peripheral blood mononuclear cells (PBMCs) of patients, who have cancer antigen identified lung cancer, will be obtained through apheresis, and T cells will be activated and ex vivo engineered.