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

Launched by WOMEN'S HOSPITAL SCHOOL OF MEDICINE ZHEJIANG UNIVERSITY · Nov 28, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for women with advanced or hard-to-treat gynecological cancers, such as cervical, ovarian, endometrial, and breast cancers. The treatment involves using tumor-infiltrating lymphocytes (TILs), which are special immune cells taken from the patient’s own tumor. These cells will be infused back into the patient after a preparatory treatment that helps the immune system be more effective. The goal is to see how well this approach works and if it is safe for patients who have not responded to other treatments.

To be eligible for this trial, participants must be women aged 18 to 75 who have been diagnosed with one of the specified cancers and have tried at least two previous chemotherapy treatments without success. Participants should also have at least one tumor that can be removed for testing and have not received any other cancer treatments for at least 28 days before the trial begins. It's important to note that this trial is still in the planning stages and is not yet recruiting participants. If someone qualifies and chooses to participate, they can expect to receive a personalized treatment plan and close monitoring from the medical team throughout the study.

Gender

FEMALE

Eligibility criteria

• 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.