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CD19 CAR T Cells in Patients With Relapsed or Refractory CD19 Positive B-cell Lymphoma (NCT03029338)

Union Stem cell & gene engineering Co.LTD
In this single-center, open-label, no control, prospective clinical trial, a total of 10 relapsed or refractory CD19 positive B-cell Non-Hodgkin Lymphoma (NHL) patients will be enrolled.CD19 CAR T cells(total dose of 2×10^6/kg-1×10^7/kg) will be intravenously infused to patient in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells in patients with relapsed or refractory CD19 positive B-cell lymphoma.
  • Biological: CD19 CAR T cells
    CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB.
    Ages eligible for Study
    18 Years to 70 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • Patients aged 18 to 70 years with relapsed or refractory CD19 positive B-cell lymphoma.
    • Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
    • Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal(ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN; Creatinine ≤ 1.5 x ULN or any serum creatinine level associated with a measured or calculated creatinine clearance of ≥ 40ml/min.
    • Male and female of reproductive potential must agree to use birth control during the study and for at least 6 weeks post study.
    • Patients should sign informed consent form.
    Exclusion Criteria:
    • Patients with central nervous system involvement by lymphoma.
    • Prior chemotherapy within 2 weeks before enrollment with the following exceptions: steroids, hydroxyurea, oral mercaptopurine, methotrexate, vincristine and thioguanine are permitted within 2 weeks of enrollment as maintenance or to reduce tumor load.
    • Prior allogeneic hematopoietic stem cell transplant (HSCT) ≤ 4 months before enrollment. Patients must have completed immunosuppression therapy prior to enrollment. At enrollment, patients must not have≥ grade 2 acute GVHD, or either moderate or severe limited chronic GVHD, or extensive GVHD of any severity.
    • Known systemic vasculitides, primary or secondary immunodeficiency(such as HIV infection or severe inflammatory disease).
    • Major surgery within 4 weeks before enrollment.
    • Impaired cardiac function:Ejection fraction ≤45 % on MUGA scan. QTc interval > 450msecs on baseline ECG. Myocardial infarction within 6 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).
    • Administration of live vaccine ≤ 4 weeks before enrollment.
    • Other concurrent severe and/or uncontrolled medical conditions: Patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.
    In this single-center, open-label, nonrandomized, no control, prospective clinical trial, a total of 10 relapsed or refractory CD19+ B-cell Non-Hodgkin Lymphoma (NHL) patients will be enrolled. CD19 CAR T cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB, will be administered by i.v. injection in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with relapsed or refractory CD19 positive B-cell lymphoma.

    1 locations

    China (1)
    • Institute of Hematology & Blood Diseases Hospital
      recruiting
      Tianjin, China, 300020
    Status:
    recruiting
    Type:
    Interventional
    Phase:
    Start:
    31 October, 2016
    Updated:
    19 January, 2017
    Participants:
    10
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