Efficacy and Safety of TILs in Treatment of Patients With Advanced or Metastatic Refractory Gynecological Cancer
NCT ID: NCT05152797
Last Updated: 2021-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
91 participants
INTERVENTIONAL
2022-01-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TILs infusion
Enrolled patients will be infused with their autologous TILs followed by IL-2 administration after post- NMA lymphodepletion
Autologous tumor-infiltrating lymphocytes
Fresh 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.
Interventions
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Autologous tumor-infiltrating lymphocytes
Fresh 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
FEMALE
No
Sponsors
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Tongji Hospital
OTHER
Qilu Hospital of Shandong University
OTHER
Sun Yat-sen University
OTHER
Women's Hospital School Of Medicine Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Hui Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Women's Hospital School Of Medicine Zhejiang University
Central Contacts
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Other Identifiers
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PRO2021-1428
Identifier Type: -
Identifier Source: org_study_id