Study on TIL for the Treatment of Advanced Breast Cancer

Launched by SHANGHAI JUNCELL THERAPEUTICS · Nov 24, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment option for advanced breast cancer using a method called tumor infiltrating lymphocyte (TIL) therapy. In this study, researchers take immune cells from a patient's own tumor and grow them in the lab before infusing them back into the patient to help fight the cancer. Participants will first undergo a short treatment to prepare their immune system before receiving the TIL therapy. The main goal is to see how safe and effective this approach is for patients whose cancer has not responded to standard treatments.

To be eligible for this trial, participants must be between 18 and 75 years old and have been diagnosed with advanced breast cancer that has either come back or spread. They should have an expected lifespan of more than three months and have at least one tumor that can be tested. It’s important that participants have already tried standard treatments or there are no other options available for them. Throughout the trial, participants will be closely monitored for any side effects and to evaluate how well the treatment works. If you're interested in learning more or think you may qualify, it’s a good idea to talk to your doctor.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age: 18 years to 75 years;
• • 2. Histologically diagnosed as primary/relapsed/metastasized breast cancer;
• • 3. Expected life-span more than 3 months;
• • 4. Karnofsky≥60% or ECOG score 0-2;
• • 5. Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.
• • 6. Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;
• • 7. At least 1 evaluable tumor lesion;
• 8. Hematology and Chemistry（within 7 days prior to enrollment）:
• • Absolute count of white blood cells≥2.5×10\^9/L;
• • Absolute count of neutropils≥1.5×10\^9/L;
• • Absolute count of lymphocytes ≥0.7×109/L；
• • Platelet count≥100×10\^9；
• • hemoglobin≥90 g/L;
• • Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);
• • International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);
• • Serum creatinine ≤1.5mg/dL(or ≤132.6μmol/L), or clearance rate≥50mL/min;
• • Serum ALT/AST ≤3×ULN(subjects with liver metastasis ≤3×ULN);
• • Totol bilirubin≤1.5×ULN;
• • 9. no absolute or relative contraindications to operation or biopsy;
• • 10. 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；
• • 11. Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs;
• • 12. Be able to understand and sign the informed consent document;
• • 13. Be able to stick to follow-up visit plan and other requirements in the agreement.
• Exclusion Criteria:
• • 1. Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
• • 2. Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;
• • 3. 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.
• • 4. 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;
• • 5. Severe physical or mental diseases;
• • 6. Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);
• • 7. Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;
• • 8. History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;
• • 9. Having received immunotherapy and developed irAE level greater than Level 3;
• • 10. 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);
• • 11. Females in pregnancy or lactation;
• • 12. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy;
• • 13. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.