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

Women's Hospital School Of Medicine Zhejiang University

Status and phase

Not yet enrolling

Phase 2

Phase 1

Conditions

Tumor Infiltrating Lymphocytes

Treatments

Biological: Autologous tumor-infiltrating lymphocytes

Study type

Interventional

Funder types

Other

Identifiers

NCT05152797

PRO2021-1428

Details and patient eligibility

About

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.

Full description

Autologous tumor-infiltrating lymphocytes (TILs) infusion is highly personalized cancer immunotherapy with strong anti-tumor efficacy and tumor specificity. TILs were extracted from autologous fresh tumor tissues, and after ex vivo stimulation, activation and extensive expansion, are reinfused to patients. TIL-based therapies have only been offered in small phase I/II studies in a few centers and revealed a high objective response rate (ORR) in the treatment of metastatic, recurrent or advanced melanoma, non-small cell long carcinoma and cervical carcinoma. However, the efficacy of TIL-based therapies still needs more clinical trials to prove. In this proposal, a one-arm, open, multicenter, phaseⅠ/Ⅱ trial was designed to evaluate the efficacy and safety of autologous tumor-infiltrating lymphocytes in treatment of patients with advanced or metastatic refractory gynecological cancer including cervical, ovarian, endometrial and breast carcinoma.

Enrollment

91 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants eligible for inclusion in this study must meet all of the following criteria: Signed informed consent must be obtained prior to participation in the study.

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
At least one measurable target lesion, that can be accurately measured in at least one dimension with longest diameter ≥20 mm, as defined by RECIST v1.1
All the chemotherapy or radiotherapy targeting the malignant tumors must be discontinued at least 28 days prior to the tumor resection.
No serious abnormality of complete blood count and Cardiac, Liver, and Kidney function

Exclusion criteria

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
Patients with serious complications of heart, lung, liver, kidney, not suitable for enrollment.
Patients with suspicious or confirmed brain metastases of any size and any number.
Suffered from any other malignancy within 5 years (except for fully treated in situ malignant such as breast cancer, bladder cancer, cutaneous basal cell carcinoma or squamous cell carcinoma)
Patients who are pregnant or breastfeeding
Any other conditions judged by the researcher will significantly increase the risk of participation.