About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Autologous tumor-infiltrating lymphocytes
Treatment groups
Locations
Sponsors and collaborators
Women's Hospital School Of Medicine Zhejiang University
Lead sponsor
Tongji Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
Sun Yat-sen University
Collaborator