Malignant Solid tumor
Conditions
Interventions
Dose-escalation group:ScTIL210
Dose-escalation group :ScTIL210
Sponsors
Shanghai Oriental Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: When patients meet all the following conditions, they can choose to enter the clinical study 1. Patients with age >= 18 years and = 3 months; 3. Patients with malignant solid tumor confirmed by histology or cytology fail to receive standard treatment, or there is no standard treatment, or standard treatment is not applicable at this stage; 4. Patients who voluntarily received peripheral blood monocytosis to obtain cells for cell preparation, and the proportion of PD1 positive T cells in the total T cells was more than 18%. For patients who had received PD1 monoclonal antibody treatment within 4 weeks before screening, the proportion of PD1 positive T cells in the total T cells was more than 12%; 5. (dose increasing stage) patients with at least one evaluable tumor focus according to RECIST version 1.1; (dose expansion stage) at least one measurable tumor focus according to RECIST version 1.1; 6. ECoG physical status score was 0 to 1; 7. Sufficient bone marrow and organ function Blood system (no transfusion or hematopoietic stimulating factor treatment within 14 days) Neutrophil count (ANC) >= 1.5 * 10^9 / L Platelet (PLT) >= 75 * 10^9 / L Hemoglobin (HB) >= 90g / L The lower limit of lymphocyte count (lym) >= 60 Lymphocyte subsets Percentage of B lymphocyte (CD19 +) in lymphocyte >= 60% of normal value liver function Total bilirubin (TBIL) <= 1.5 * ULN Alanine aminotransferase (ALT) <= 3 * ULN; Patients with liver metastasis or liver cancer: <= 5 * ULN Aspartate aminotransferase (AST) <= 3 * ULN; Patients with liver metastasis or liver cancer: <= 5 * ULN renal function Creatinine <= 1.5 * ULN Coagulation function Activated partial thromboplastin time (APTT) <= 1.5 * ULN International normalized ratio (INR) <= 1.5 * ULN 8. Eligible fertile patients (male and female) must agree to use reliable contraceptive methods (hormonal or barrier method or abstinence, etc.) with their partners during the trial and at least 90 days after the last medication; women of childbearing age (as defined in Appendix 8) must have a negative blood or urine pregnancy test within 7 days before the first use of the study drug; 9. The subjects should be informed of the study before the trial and sign the written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: When a patient has one of the following conditions, he can not be selected for clinical study 1. Patients who have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, Chinese medicine with anti-tumor indications and other anti-tumor treatment within 2 weeks before single collection, except for the following items: (1) Nitrosourea or mitomycin C was within 6 weeks before harvest; (2) Oral administration of fluorouracil and small molecule targeted drugs was one week before single collection. 2. Patients who have received other unlisted clinical research drugs or treatments within 4 weeks before single collection; 3. Patients who had undergone major organ surgery (excluding biopsy) or had significant trauma within 4 weeks before single collection, or required elective surgery during the trial period; 4. Patients who have received systemic corticosteroids (prednisone > 10mg / day or equivalent dose of the same drug) or other immunosuppressants within 14 days before the single collection; Except for the following: topical, ocular, intra articular, nasal and inhaled glucocorticoids; short-term use of glucocorticoids for preventive treatment (e.g., prevention of contrast media allergy); and; 5. Patients who have used immunomodulatory drugs within 14 days before single collection, including but not limited to thymosin, interleukin-2, interferon, etc; 6. Patients who have used live attenuated vaccine within 4 weeks before collection; 7. Patients whose adverse reactions of previous anti-tumor therapy have not recovered to CTCAE 5.0 level or less (except for toxicity with no safety risk judged by researchers such as alopecia); 8. Patients with central nervous system metastasis or meningeal metastasis with clinical symptoms, or with other evidence indicating that the central nervous system metastasis or meningeal metastasis has not been controlled, it is not suitable to be included in the study; 9. Patients with active infection within one week before single collection and who need systemic anti infection treatment at present; 10. Patients with a history of immunodeficiency, including HIV antibody positive patients; 11. Patients with hepatitis B (HBsAg positive and / or hepatitis C (anti HCV positive) and / or Treponema pallidum antibody positive patients; 12. Patients with interstitial lung disease at present; 13. Patients with a history of severe cardiovascular and cerebrovascular diseases, including but not limited to: (1) Patients with severe cardiac rhythm or abnormal conduction, such as ventricular arrhythmia, II - III degree atrioventricular block, etc. (2) Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other cardiovascular and cerebrovascular events of grade 3 or above occurred within 6 months before the first administration. (3) New York Heart Association (NYHA) cardiac function grade >= II or left ventricular ejection fraction (LVEF) less than 50%, or other researchers judge that there is a high risk of structural heart disease; (4) Clinically uncontrollable hypertension. 14. Patients with active or previous autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.) with active or previous autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), excluding patients with clinically stable autoimmune thyroid disease and well controlled type I diabetes mellitus; 15. Pa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;DCR;DOR;PFS;OS; | — |
Countries
China
Contacts
Public ContactJin Li
Shanghai Oriental Hospital
Outcome results
None listed