Efficacy and Safety of TILs in Treatment of Patients With Advanced or Metastatic Refractory Gynecological Cancer

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorWomen's Hospital School Of Medicine Zhejiang University

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

91 Participants
are divided into 1 treatment group

Locations

This trial has no 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