Cancer
Conditions
Interventions
Case series:Drug: Cyclophosphamide On days -6 through -5, Cyclophosphamide 1g/m^2/day IV will be infused over 60 minutes. Drug: Fludarabine On days -4 through -2, Fludarabine 30mg/m^2/day IV will be i
Sponsors
Shenzhen Second People's Hospital
Eligibility
Sex/Gender
All
Age
14 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 14 and 80 years; 2. Patients with pathological or cytologically confirmed, non-surgical resection, advanced metastatic or relapsed refractory solid malignancies, including lung cancer, melanoma, synovium Sarcoma and bladder cancer; 3. Patients fail to respond to first-line standard therapy, cannot tolerate or refuse chemotherapy; 4. Patient with at least one measurable lesion; 5. Patient must be human leukocyte antigen HLA-A2 + and cancer cells express NY -ESO-1 (> 30% cancer cells) cancer; 6. Patient have ability to understand and sign informed consent; 7. Eastern Cooperative Oncology Group (ECOG) score: 0-2; 8. Life expectancy> 3 months; 9. Women at childbearing age have a negative urine pregnancy test before enrollment, and patients (including men and women) agree to take effective contraceptive measures throughout the clinical trial; 10. Non-pregnant and lactating patients; 11. Biochemical test: serum alanine aminotransferase / aspartate aminotransferase <=2.5 NUL, serum creatinine <= 1.6 mg/dl, total bilirubin <=1.5 mg/dl; 12. inactive hepatitis B virus (HBV) and / Or Hepatitis C virus (HCV) infection; 13. human immunodeficiency virus (HIV) antibody serum negative; 14. Patient is at least 4 weeks away from any previous systemic and systemic test drug treatment, And the toxic and side effects must return to level 1 or lower; 15. Patient who has received any antibody (anti-CTLA4, anti-PD1 or anti-PD-L1) treatment before, only can be involved after 6 weeks of treatment to reduce the antibody level.
Exclusion criteria
Exclusion criteria: 1. The patient needs urgent treatment due to tumor compression symptoms such as intestinal obstruction or vascular compression; 2. Patient suffering from acute hemolytic anemia; 3. Patients with uncontrollable infectious diseases within 2 weeks before enrollment; 4. HIV seropositive patients; 5. patients with active HBV and / or HCV infection; 6. Patients with a history of brain metastases or any residual intracranial implants; 7. Coagulopathy or other cardiovascular, Major diseases such as the respiratory system or immune system; 8. Patients with any form of primary immunodeficiency (such as severe combined immunodeficiency disease); 9. patients with concurrent opportunistic infections; 10. Patients with a history of severe immediate allergies to the drug used in this study; 11. Pregnant or lactating women; 12. Patients with mental illness; 13. Patients who have previously used any gene therapy products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the effectiveness of TCR-T cells in the treatment of advanced relapsed or refractory malignant solid tumors;Assess the safety and feasibility of TCR-T cells for advanced relapsed or refractory malignant solid tumors; | — |
Countries
China
Contacts
Public ContactGeng Tian
Shenzhen Second People's Hospital
Outcome results
None listed