Advanced solid tumor
Conditions
Interventions
Experimental group:Hi-TCR-T cell injection targeting Nectin4/NKG2DL/FAP
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-70 years old (including 70 years old), male or female; 2) Advanced recurrent or metastatic solid tumors confirmed by histological or cytological evaluation and that have failed standard therapy, or currently no standard therapy is available; 3) The presence of at least one measurable lesion according to RECIST 1.1 criteria; 4) by the immunohistochemical detection, tumor cells Nectin4 / NKG2DL/TROP2 / B7H3 / FAP express some positive (at least two targets positive); 5) ECOG physical condition score is 0-2 points; 6) Major organ function is normal, that is, meet the following criteria: ? Blood routine examination: hemoglobin =90 g/L; Absolute neutrophil count (ANC) =1.5×10^9/L; Platelet count =100×10^9/L; ? Blood biochemical test: serum albumin =28 g/L; Total bilirubin =2× upper limit of normal (ULN); Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =3×ULN; Alkaline phosphatase (ALP) =3×ULN; Creatinine =1.5×ULN; ? Coagulation function: International standardized ratio (INR) or prothrombin time (PT) =1.5×ULN; Activated partial thromboplastin time (APTT) =1.5×ULN; ? Echocardiography showed normal diastolic function, left ventricular ejection fraction (LVEF) =50%, and no serious arrhythmias. ? No serious lung or kidney disease, no active lung infection. Indoor air blood oxygen saturation =92%; 7) The subjects had no contraindications for peripheral blood monopexy; 8) Expected survival time =3 months.
Exclusion criteria
Exclusion criteria: 1) Uncontrolled active infection or expected to receive systemic anti-infection or immunosuppressive therapy during the study; 2) Received chemotherapy, radiotherapy or surgery within 4 weeks prior to chemotherapy preconditioning; 3) Received targeted drug therapy within 2 weeks before chemotherapy preconditioning; 4) Any toxicity caused by previous antitumor therapy before chemotherapy preconditioning has not returned to grade 1 or below (CTCAE version 5.0); 5) Have a previous history of organ/stem cell transplantation, or expect to require organ/stem cell transplantation during the study; 6) History of primary malignancies of other systems within the past 3 years (except cervical carcinoma in situ); 7) Active central nervous system disease or known concomitant brain metastases with significant neurological/psychiatric symptoms as assessed by MMSE; 8) Known allergy to 2 or more non-similar foods/drugs, or known allergy to chemotherapy preconditioning drugs (including cyclophosphamide, fludarabine, interleukin); 9) HIV infection; 10) Pregnant or lactating women; 11) The investigator believes that the subjects have other conditions that are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;TTP;OS;QOL; | — |
Countries
China
Contacts
Public ContactHaiyan Hu
Shanghai Sixth People's Hospital
Outcome results
None listed