Advanced solid tumors
Conditions
Interventions
experimental group:Chimeric antigen receptor gene-modified autologous T cells injection 0.5x10^7 /kg-5x10^7 /kg, intravenous drip, single-dose
Sponsors
Jiangsu Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Pathologically confirmed patients with solid tumors such as patients with advanced ovarian cancer or pancreatic cancer or malignant mesothelioma; 3. The patients relapsed after undergone standard second-line treatment such as chemotherapy, or targeted therapy and or above; 4. The histopathological results of the patient's tumor are antigen expression, such as mesothelin>=15%; 5. The patient has at least one tumor and can be accurately measured at baseline. The longest diameter at baseline >=10mm (if it is a lymph node, the short diameter is required to be greater than or equal to 15mm); 6. ECOG score 0~2, minimum expected survival is 12 weeks; 7. Have enough venous access for apheresis or venous blood collection; 8. The patient himself participated voluntarily and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Chemotherapy or radiotherapy was used within 3 days before blood collection; 3. Systemic steroid use within 5 days before blood collection (recent or current use) Except inhaled steroids); 4. The patients who used drugs to stimulate the production of bone marrow hematopoietic cells within 5 days before blood collection period; 5. Those who have used any gene or cell therapy products; 6. History of epilepsy or other central nervous system diseases; 7. Active hepatitis B or hepatitis C virus, defined as: hepatitis B surface antigen HBsAg Or hepatitis B core antibody HBcAb positive and peripheral blood HBV DNA titer detection is higher than the upper limit of detection Of the subjects; HCV antibody and HCV RNA in peripheral blood of patients with hepatitis C were positive; AIDS Patients infected with HIV and syphilis; 8. Patients with other tumors in the past 5 years; 9. Patients with severe pleural effusion and ascites; 10. Within 14 days before enrollment, there were active or uncontrollable infections requiring systemic treatment; 11. Within twow eeks before the start of the study, other anti-tumor treatments (except pretreatment chemotherapy) were used; 12. The investigator assessed that the patient was unable or unwilling to comply with the requirements of the research protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events related to CAR-T cell reinfusion;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress Free Survival;Duration of Response;Disease Control Rate;Overall Survival; | — |
Countries
??
Contacts
Public ContactShu Yongqian
Jiangsu Provincial Hospital
Outcome results
None listed