Status:
RECRUITING
Study on TIL for the Treatment of r/r Gynecologic Tumors
Lead Sponsor:
Shanghai 10th People's Hospital
Collaborating Sponsors:
Shanghai Juncell Therapeutics
Conditions:
Gynecologic Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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;
- 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
- 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;
- 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.
Key Trial Info
Start Date :
January 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04766320
Start Date
January 4 2021
End Date
January 31 2025
Last Update
March 6 2024
Active Locations (1)
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1
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China, 200040