Advanced malignant solid tumors
Conditions
Interventions
Experimental group1:first dose
Experimental group2:second dose
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years; 2. Expected natural survival period >= 3 months; 3. Patients with histologically or cytologically confirmed melanoma (acral type and mucosal type), biliary tract tumor, pancreatic cancer, and cervical cancer, who have failed standard treatment, or have no standard treatment plan, or are not suitable for standard treatment at this stage, or the patient refuses to accept conventional treatment regimens; 4. Voluntarily accept peripheral blood apheresis and/or surgery to obtain sufficient fresh tumor tissue for cell preparation, and peripheral blood PD1-positive T cells account for >=18% of total T cells, and have received PD1 monoclonal before screening In patients treated with antibodies, the proportion of PD1-positive T cells in peripheral blood >= 12% of total T cells; (detection standard by BD Accuri C6 flow cytometer) 5. According to RECIST version 1.1, there is at least one measurable lesion shown by CT or MRI examination (measurable lesions are defined as the longest diameter of tumor lesions >= 10 mm and the short diameter of metastatic lymph nodes >= 15 mm under the condition that the scanning thickness does not exceed 5.0 mm). ); 6. Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 1; 7. No serious hematology, liver and kidney function abnormalities, consistent with the following laboratory test results: no blood transfusion, no Granulocyte colony stimulating factor (G-CSF) treatment, no use within 14 days before screening Under the premise of drug correction (1) Neutrophil count >=1.5x10^9/L; (2) Platelet count >=75x10^9/L; (3) Hemoglobin >=90 g/L; (4) the normal range of lymphocyte count; (5) C-reactive protein = the lower limit of normal; (7) Biochemical indicators: 1) Total bilirubin (TBIL) = 3.0g/dL, serum creatinine (Cr) <= 1.5 upper limit of normal (ULN) Note: Patients with liver metastases or liver cancer: AST and ALT <= 5 ULN; (8) Coagulation function: 1) Activated partial thromboplastin time (APTT) <= 1.5 ULN; 2) International normalized ratio (INR) <= 1.5 ULN; urine routine: urine protein concentration <= 1+, without edema. 8. Eligible patients (male and female) of childbearing potential must agree to use reliable contraceptive methods (hormonal or barrier method or abstinence, etc.) with their partners during the trial and for at least 90 days after the last dose; females of childbearing age (15- 49 years old) The patient must have a negative blood or urine pregnancy test within 7 days before the first use of the study drug; 9. Subjects must be informed of the study before the trial, be able to follow the clinical research protocol and follow-up procedures, and voluntarily sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, traditional Chinese medicine with anti-tumor indications and other anti-tumor treatments within 2 weeks before apheresis, except for the following: (1) nitrosoureas or mitomycin C within 6 weeks before apheresis; (2) Oral fluorouracil and small molecule targeted drugs should be taken 1 week before apheresis. 2. Received systemic glucocorticoid (prednisone>10mg/day or equivalent dose of similar drugs) or other immunosuppressive therapy within 2 weeks before apheresis; except for the following cases: short-term use of glucocorticoids prophylactic treatment (eg, prophylaxis of contrast medium allergy); 3. Use of immunomodulatory drugs, including but not limited to thymosin, interleukin-2, interferon, etc., within 2 weeks before apheresis; 4. Received other unmarketed clinical research drugs or treatments within 4 weeks before apheresis; 5. Received major organ surgery (excluding needle biopsy) within 4 weeks before apheresis, or had significant trauma, or required elective surgery during the trial (except for the operation to obtain fresh STIL tumor tissue); 6. Use of live attenuated vaccine within 4 weeks before apheresis; 7. Patients with clinical symptoms or untreated brain metastases or meningeal metastases (of any size and number), or other evidence that the patient's brain metastases or meningeal metastases have not been controlled; 8. Patients with dual primary cancers and the first primary cancer has been cured for less than 5 years; 9. Hepatitis B: HBsAg(+) or HbeAg(+); or anti-HBe(+)/anti-HBc(+) at the same time, the quantification of hepatitis B DNA is higher than the detection limit of the research center; hepatitis C: anti-HCV positive; Treponema pallidum antibody (+); 10. Have a history of immunodeficiency, including positive HIV antibody test; 11. Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to: (1) Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia, II-III degree atrioventricular block, etc. requiring clinical intervention; (2) Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or above cardiovascular and cerebrovascular events occurred within 6 months before the first administration; (3) New York Heart Association (NYHA) cardiac function class >= grade II or left ventricular ejection fraction (LVEF) =3; 15. Uncontrollable serous cavity effusion, judge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;6-month progression-free survival;duration of relief;disease control rate;overall survival;Adverse events;Detection of carrier gene copy number;ctDNA sequencing before and after cell treatment; | — |
Countries
China
Contacts
Public ContactLiu Jingfeng
Fujian Cancer Hospital
Outcome results
None listed