Prospective, multicenter, single-arm, open label, interventional basket trial to evaluate autologous tumor-infiltrating lymphocytes (TILs) infusion followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparation for the treatment of patients with advanced or metastatic refractory gynecological cancer including cervical, ovarian, endometrial and breast carcinoma.
Aged 18-75 years old at the time of consent
Participants are diagnosed with advanced or metastatic cervical cancer, ovarian cancer, endometrial cancer or breast cancer with radiology and pathology confirmation.
Failure of two or more Lines of Chemotherapy, or not amenable to curative treatment.
At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to extract TIL
Participants who have received organ transplantation or prior cell transfer therapy
Any active autoimmune disease or history of autoimmune disease, or history of primary immunodeficiency.
Patients who are taking systemic steroid therapy
Patients with confirmed HIV infection, or other uncontrolled active viral infections, or serious system infections
Single group
Autologous tumor-infiltrating lymphocytes
Biological/VaccineFresh tumor samples will be resected from enrolled patients. Autologous TILs will be extracted and reinfused to corresponding patients after ex vivo stimulation, activation and extensive expansion.
Objective Response Rate
To evaluate the efficacy of TILs in patients with advanced or metastatic refractory malignant gynecological cancer including cervical, ovarian, endometrial and breast carcinoma based on the objective response rate (ORR) as assessed by the Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Disease Control Rate
To evaluate the efficacy of TILs in patients with advanced or metastatic refractory gynecological cancer including cervical, ovarian, endometrial and breast carcinoma based on the disease control rate (DCR) as assessed by the IRC per RECIST v1.1
Progression-Free Survival
To evaluate the efficacy of TILs in patients with advanced or metastatic refractory gynecological cancer including cervical, ovarian, endometrial and breast carcinoma based on the progression-free survival (PFS) as assessed by the IRC per RECIST v1.1
Overall Survival
To evaluate overall survival (OS) in patients with advanced or metastatic refractory gynecological cancer including cervical, ovarian, endometrial and breast carcinoma
Adverse Events
To characterize the safety profile of TILs in patients with advanced or metastatic refractory gynecological cancer including cervical, ovarian, endometrial and breast carcinoma as assessed by incidence of adverse events
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Women's Hospital School Of Medicine Zhejiang University
Lead sponsor
Tongji Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
Sun Yat-sen University
Collaborator
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