The purpose of this study is to observe and confirm the safety, tolerance and cell
pharmacokinetics of lentivirus-transduced CAR-GPC3 T cells (CAR-GPC3 T cells targeting GPC3)
Genetic: CAR-GPC3 T Cells
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Full eligibility criteria for NCT02876978
Ages eligible for Study
18 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
Men or women aged 18~70 years old
Subjects are diagnosed as refractory, recurrent ,metastatic, advanced lung squamous cell carcinoma by histological and cytological methods including specific lesion-targeted brush biopsy, lavage and fine needle aspiration;
Have at least one new measurable tumor lesion compared with previous irradiated region
Tumor tissues samples confirmed as GPC3-positive
Expected survival≥12 weeks
ECOG scored as 0-1 or KPS grading > 80
Serum creatinine≤2.5mg/dL，CCR≥50ml/min (renal malfunction defined as CCR＜50ml/min according to Cockroft-Gault formula)
ALT and AST≤2.5ULN; for liver metastasis，ALT and AST ≤5ULN
Serum TBiL≤3.0mg/dL, TBiL≤2.5ULN
PT: INR < 1.7 or extended PT to normal value < 4s
Adequate venous access for apheresis or venous blood collection, and no other contraindication of blood cell separation
Patients with willingness to be in this study and able to provide informed consent
Capable of receiving treatment and follow up, included subjects are required to receive treatment in the enrolled centre
Women of childbearing age are required to take acceptable measures to minimize the possibility of pregnancy during whole session. Women of childbearing age must have negative results of serum or urine tests within 24 hours prior to infusion. Women subjects must not be in lactation;
CAR-T positive rate < 10%
pregnant women or women in lactation
active HBV or HCV infection
previously suffered from diseases or concurrent diseases as followed：
patients confirmed as severe autoimmune diseases in long-term (over 2 months) need of systemic immune inhibitors (steroid) or as immune-mediated symptomatic diseases including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune vasculitis (for example, Wegener's granulomatosis)
subjects with previous diagnosis as motor neurone disease caused by autoimmunity
subjects previously suffered from toxic epidermal necrolysis (TEN)
subjects with any mental diseases including dementia, mental status change that may impinge the understanding and performance of informed consent and related questionnaire
subjects with severe, uncontrollable diseases judged by investigators that may hinder them receiving this treatment
subjects with previously active malignant tumors including basal or squamous skin cancer, superficial bladder cancer, and in situ breast carcinoma within 5 years who had been completely cured without the need of follow-up treatment are not excluded.
during ongoing treatment using systemic steroid or steroid inhalants
previous treatment used gene therapy products
previous experience of immunotherapies including CIK, DC, DC-CIK, LAK for the treatment of cancer
allergic to immunotherapies or related drugs
patients in need of treatment for heart disease with ≥2 NYHA or for poor controlled hypertension
subjects with unstable or active peptic ulcer or alimentary tract hemorrhage
subjects with previous organ transplantation or ready for organ transplantation
subjects in need of anticoagulant therapy treatment (warfarin or heparin)
subjects judged by investigators as not appropriate for this study
All locations for NCT02876978
Shanghai General Hospital
Shanghai, Shanghai, China, 200030
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View full eligibility
Tris trial is registered with FDA with number: NCT02876978. The sponsor of the trial is Carsgen Therapeutics, Ltd. and it is looking for 20 volunteers for the current phase.
Official trial title: Preliminary Clinical Study of Autologous T Cells Modified Chimeric Antigen Receptor (CAR) Targeting GPC3 for the Treatment of Recurrent or Refractory Lung Squamous Cell Carcinoma
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