hepatocellular carcinoma and lung squamous cell carcinoma
Conditions
Interventions
dose:chimeric antigen receptor gene-modified autologous T cells targeting GPC3
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18-70 (including 18 and 70 years of age); 2. Survival is expected to be greater than 12 weeks; 3. Pathology confirmed as hepatocellular carcinoma (HCC) or squamous cell carcinoma of the lung (LSC), for liver cancer patients, previously received at least one of the following treatment and progress: local treatment (including ablation, vascular intervention, external radiation therapy) Including sorafenib treatment, including oxaliplatin treatment; for patients with squamous cell carcinoma of the lung, the need to identify at least two previous treatment failure; 4. Positive by GPC3 by IHC test; 5. There is at least one measurable target lesion (= 10 mm); 6. ECOG status 0-1, KPS score> 70 points; for patients with hepatocellular carcinoma, the need to meet Child-Pugh rating A or score 7 of the B-level; 7. with a single vein or vein blood collection sufficient venous access, and no other blood cell separation contraindications; 8. Blood test: WBC = 2.5 × 10^9/L, PLT = 60 × 10^9/L, Hb = 9.0g/dL, MID = 1.0 × 10^9/L, LY = 0.4 × 10^9/L, LY% = 15%; 9. Serum biochemistry: serum Alb = 30 g/L, serum lipase and amylase <1.5 ULN, serum creatinine = 1.5 ULN; for patients with hepatocellular carcinoma, ALT = 5 ULN, AST = 5 ULN, for lung squamous cell carcinoma patients, ALT = 2.5 ULN, AST = 2.5 ULN; total bilirubin = 2.5 ULN; 10. Coagulation test: PT: INR <1.7; 11. Understand and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Transduction-positive T cells stimulation <5-fold; 2. Pregnant or lactating women; 3. HIV positive; 4. Left ventricular ejection fraction (LVEF) = 45%, or obvious ECG abnormalities; 5. There are significant pulmonary ventilation dysfunction, FEV1 / FVC <70%; 6. Any uncontrollable active infection; 7. Steroid drugs are currently being used systemically, recent or current use of inhaled steroids are not excluded; 8. Immunotherapy and related drug allergy; 9. There is currently a need for treatment of heart disease or by the researchers to determine the poor control of high blood pressure; 10. Patients with unstable or active gastrointestinal or respiratory bleeding present or currently undergoing anticoagulation with drugs such as warfarin or heparin; 11. Patients with a history of organ transplants or patients awaiting organ transplants; 12. Study of the beginning (blood) 4 weeks before the study of the disease for chemotherapy, the use of targeted anti-tumor drugs or interventional therapy for cancer; 13. Other concomitant antineoplastic therapies; 14. The investigator assessed the requirement that the patient was unable or unwilling to comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability;In vivo sustained survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DCR;OS;Peripheral blood immune parameters; | — |
Countries
China
Contacts
Public ContactWang Hongxia
Shanghai General Hospital
Outcome results
None listed