Clinical Trials /

The Study of Targeted NY-ESO-1 T Cell Receptor (TCR) Genetic Modified Autologous T Cells Treatment of Advanced Solid Tumors

NCT03047811

Description:

The study of targeted NY-ESO-1 T cell receptor (TCR) genetic modified autologous T cells treatment of advanced solid tumors 1. The main purpose - security and ORR; 2. A secondary purpose - median progression-free surial;1 year, 2 years, total 5 years survival rate;The quality of life.

Related Conditions:
  • Esophageal Carcinoma
  • Lung Carcinoma
  • Melanoma
Recruiting Status:

Unknown status

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: The Study of Targeted NY-ESO-1 T Cell Receptor (TCR) Genetic Modified Autologous T Cells Treatment of Advanced Solid Tumors
  • Official Title: The Study of Targeted NY-ESO-1 T Cell Receptor (TCR) Genetic Modified Autologous T Cells Treatment of Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: NY-TCR WXH 2016
  • NCT ID: NCT03047811

Conditions

  • Advanced Malignant Solid Tumors

Purpose

The study of targeted NY-ESO-1 T cell receptor (TCR) genetic modified autologous T cells treatment of advanced solid tumors 1. The main purpose - security and ORR; 2. A secondary purpose - median progression-free surial;1 year, 2 years, total 5 years survival rate;The quality of life.

Trial Arms

NameTypeDescriptionInterventions
TCR - T cell therapyExperimentalPeripheral blood mononuclear cells collected: draw 100-150 ml of peripheral blood in patients and separate of the peripheral blood mononuclear cells, the total number of cells 1.5 * 10 ^ 7 / kg - 1 * 10 ^ 8 / kg Fludarabine 25 mg/m2 + NS 250 ml, ivgtt qdx5d, CTX 60 mg/kg + NS 250 ml, ivgtt qd x2d, should be in front of the TCR - T cells infusion of 4 days reinfusion the total number of T cells (1* 10 ^ 8 / kg - 10 * 10 ^ 8 / kg) in 3 days , infusion 10-15 minutes, should not be more than 20 minutes.

    Eligibility Criteria

            Inclusion Criteria:
    
            3.1.1 volunteered for the clinical research and signed informed consent. 3.1.2 aged 18-70,
            expected lifetime > 3 months. 3.1.3 gender not limited. 3.1.4 late lung cancer (stage
            IIIb/IV), (IV) with esophageal carcinoma, and melanoma (advanced), no other effective cure
            Treatment method can be selected patients. 3.1.5 biopsy IHC confirmed positive expression,
            NY - ESO - 1 or 50% of the tumor cells IHC staining in 2 + and/or 3 +.Organization based on
            time in the group in the year before, can be a tumor tissue, can also be a pleural effusion
            cells
    
            Exclusion Criteria:
    
            3.2.1 this study used in the process of cell preparation ingredients allergy, such as
            penicillin, streptomycin.
    
            3.2.2 used within a week of tyrosine kinase inhibitors (the treatment such as, for it), or
            other cancer drugs.
    
            3.2.3 is systemic anti-cancer therapy, including immune therapy, such as accept the immune
            cells within a month back to lose Therapy or biological treatment.6 weeks used cancer
            associated with tumor immune single resistance (including the PD, PD - L1 and - 1 CTLA 4
            single resistance). 3.2.4 have vital organs, such as cardiovascular, respiratory system
            disease, myocardial infarction, myocardial ischemia, the coronary artery bypass History or
            coronary ischemia symptoms, obstructive or restrictive lung disease. 3.2.5 the patient's
            immune tolerance is poor, may on the immune cells in treatment of the reaction of low or
            prone to toxic reactions.
    
            3.2.6 always have autoimmune and immunodeficiency disease. 3.2.7 radiation pneumonitis.
            3.2.8 depends on oxygen. 3.2.9 four weeks into the set of other therapeutic studies or
            clinical trials. 3.2.10 used experimental vaccine in two months 3.2.11 systemic
            corticosteroids used within two weeks, hydroxyurea or immune inhibitors (such as IL - 2,
            Interferons alpha, IFN - gamma, GSF, mTOR inhibitors, ring spore element, etc.).Recently or
            are using suction The sex hormone. 3.2.12 year have chronic or recurrent severe autoimmune
            diseases. 3.2.13 uncontrolled active infection. 3.2.14 2-4 acute or persistent during graft
            versus host disease (GVHD). 3.2.15 serious heart disease, after treatment of the disease is
            still unstable, into the group of the first six months after myocardial infarction, and
            congestion Heart failure, unstable angina, symptoms of pericardial effusion or unstable
            arrhythmia.
    
            3.2.18 always suffer from other cancers, but does not include: A. basal cell carcinoma and
            squamous cell carcinoma after active treatment, the wound healed completely.
    
            B. the cervical or breast carcinoma in situ cure for at least three years. C. primary
            malignant tumors were removed completely, completely relieve five years or more.
    
            3.2.19 accompanied by primary or secondary brain tumor patients. 3.2.20 the mentally
            disabled. 3.2.21 doubt or have alcohol and drug abuse history. 3.2.22 physicians determine
            cannot or may not be able to complete the test subjects.
    
            3.2.23 any not listed may interfere with the patient to participate in the active disease.
          
    Maximum Eligible Age:70 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:overall survival (OS)
    Time Frame:From date of randomization until the date of date of death from any cause, whichever came first, assessed up to 36 months
    Safety Issue:
    Description:

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Fudan University

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