A Clinical Safety and Efficacy Study on TIL for the Treatment of r/r Gynecologic Tumors

Shanghai 10th People's Hospital1 site in 1 country15 target enrollmentJanuary 4, 2021

ConditionsGynecologic Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Gynecologic Cancer
Sponsor: Shanghai 10th People's Hospital
Enrollment: 15
Locations: 1
Primary Endpoint: Incidence of Serious Adverse Events (SAEs)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with malignant refractory/relapsed gynecologic tumors. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with fludarabine and cyclophosphamide.

Registry

clinicaltrials.gov

Start Date

January 4, 2021

End Date

January 31, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Shanghai 10th People's Hospital

Responsible Party

Principal Investigator

Zhongping Cheng

Director of Department of Gynecology and Obstetrics

Shanghai 10th People's Hospital

Eligibility Criteria

Inclusion Criteria

•Age: 18 years to 75 years;
•Histologically diagnosed as primary/relapsed/metastasized malignant tumors;
•Expected life-span more than 3 months;
•Karnofsky≥60% or ECOG score 0-2;
•Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.
•Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;
•At least 1 evaluable tumor lesion;
•Absolute count of white blood cells≥2.5×10\^9/L, absolute count of neutropils≥1.5×10\^9/L, platelet count≥100×10\^9, hemoglobin≥90 g/L;
•Serum creatinine clearance 50mL/min or higher; creatinine≤1.5×ULN; ALT/AST less than three times that of normal group, ALT/AST of test subjects with liver metastasis less than five times that of normal group; bilirubin≤1.5×ULN;
•Activated partial thromboplastin time (APTT) less than or equal to 1.5xULN; international normalized ratio (INR) less than or equal to 1.5xULN;

Exclusion Criteria

•Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones);
•Autoimmune diseases requiring immunomodulatory treatment;
•Serum creatinine \>1.5×ULN; serum glutamic-oxalacetic transaminase (SGOT) greater than 5×ULN; bilirubin \>1.5×ULN;
•Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;
•Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc.
•Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;
•Severe physical or mental diseases;
•Blood culture positive or imaging proof;
•Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;
•History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;

Outcomes

Primary Outcomes

Incidence of Serious Adverse Events (SAEs)

Time Frame: Up to 12 months

Safety assessments. Incidence of Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events (TEAEs). The severity of all adverse events was graded based on Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.