Study on TIL for the Treatment of Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Apr 22, 2024
  • participants needed
    20
  • sponsor
    Shanghai Gencells Therapeutics Co., Ltd.
Updated on 17 November 2021

Summary

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with Advanced malignant solid 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 Advanced Solid Tumors
Treatment Tumor Infiltrating Lymphocytes (TIL)
Clinical Study IdentifierNCT04967833
SponsorShanghai Gencells Therapeutics Co., Ltd.
Last Modified on17 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Hematology and Chemistrywithin 7 days prior to enrollment
Absolute count of white blood cells2.510^9/L
Absolute count of neutropils1.510^9/L
Absolute count of lymphocytes 0.7109/L
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
Platelet count10010^9
hemoglobin90 g/L
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
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)
Be able to stick to follow-up visit plan and other requirements in the agreement
Serum creatinine 1.5mg/dL(or 132.6mol/L), or clearance rate50mL/min
Serum ALT/AST 3ULN(subjects with liver metastasis 3ULN)
Totol bilirubin1.5ULN
No absolute or relative contraindications to operation or biopsy

Exclusion Criteria

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
Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy
Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment
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
Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection)
History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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