This trial plans to enroll many patients with advanced solid tumors to complete GK01 cell transfusion, including but not limited to advanced gastric cancer, esophageal cancer, cervical cancer, triple-negative breast cancer, and non-small cell lung cancer. For patients with advanced solid tumors eligible for inclusion, autologous tumor-reactive T cells (experimental drug GK01) were cultured and prepared, and a certain dose of GK01 cells was given according to the cell transfusion plan, and the safety and tolerability of the patients after transfusion were observed. Exploratory evaluation of pharmacokinetic/pharmacodynamic profiles following reinfusion and initial evaluation of efficacy of investigational drug GK01 cells according to RECIST 1.1 criteria.
18≤ age ≤75 years old, male or female;
Patients with incurable advanced gastric cancer, esophageal cancer, cervical cancer, triple-negative breast cancer, non-small cell lung cancer, and other malignancies who have failed standard treatment (standard treatment failure is defined as those treated according to the 2022 CSCO Guidelines and whose tumor efficacy is assessed as disease progression (PD) or tumor recurrence or inability to tolerate existing treatment options);
There are tumor tissues or cancerous exudative thoracoabdominal fluid that can be used to isolate TRTs: the total volume of the solid tissue taken must be > 0.5cm3 or the weight must be >0.5g, the cancerous exudative thoracoabdominal fluid taken should contain at least 5×10^8 total cells, and the lesions taken have not been treated with oncolytic virus.
There is at least one measurable lesion (according to RECIST1.1 criteria) even after TRTs sampling/puncture biopsy;
Prior allergy to cyclophosphamide, fludarabine and interleukin-2 contraindications or to any component of the infusion product formulation or to other drugs to be used during the study (antibiotics, human serum albumin, dextran 40, etc.);
Any NCI CTCAE5.0 immune-related adverse reaction (irAE) grade >3 that has been permanently discontinued during any previous immunotherapy;
Patients with prior primary immunodeficiency and active autoimmune disease;
Previous history of organ allotransplantation, allogeneic stem cell transplantation and kidney replacement therapy;