Study on TIL for the Treatment of r/r Gynecologic Tumors

  • STATUS
    Recruiting
  • End date
    Jan 31, 2024
  • participants needed
    50
  • sponsor
    Shanghai 10th People's Hospital
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Updated on 28 February 2021
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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.

Details
Condition Gynecologic Cancer
Treatment Tumor Infiltrating Lymphocytes (TIL)
Clinical Study IdentifierNCT04766320
SponsorShanghai 10th People's Hospital
Last Modified on28 February 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Are you female?
Do you have any of these conditions: Do you have Gynecologic Cancer??
Age: 18 years to 75 years
Histologically diagnosed as primary/relapsed/metastasized malignant tumors
Expected life-span more than 3 months
Karnofsky60% 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 cells2.510^9/L, absolute count of neutropils1.510^9/L, platelet count10010^9, hemoglobin90 g/L
Serum creatinine clearance 50mL/min or higher; creatinine1.5ULN; 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; bilirubin1.5ULN
Activated partial thromboplastin time (APTT) less than or equal to 1.5xULN; international normalized ratio (INR) less than or equal to 1.5xULN
Enough venous accessibility, no absolute or relative contraindications to operation or biopsy
Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent, and continue within 1 year after the completion of lymphodepletion
Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs
Be able to understand and sign the informed consent document
Be able to stick to follow-up visit plan and other requirements in the agreement

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 >1.5ULN; serum glutamic-oxalacetic transaminase (SGOT) greater than 5ULN; bilirubin >1.5ULN
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
Having received immunotherapy and developed irAE level greater than Level 3
Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded)
Females in pregnancy or lactation
Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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