Spots Global Cancer Trial Database for CD19 CAR T Cells in Patients With Relapsed or Refractory CD19 Positive B-cell Lymphoma

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Trial Identification

Brief Title: CD19 CAR T Cells in Patients With Relapsed or Refractory CD19 Positive B-cell Lymphoma

Official Title: CD19 CAR T Cells in Patients With Relapsed or Refractory CD19 Positive B-cell Lymphoma

Study ID: NCT03029338

Conditions

Lymphomas Non-Hodgkin's B-Cell

Relapse

Interventions

CD19 CAR T cells

Study Description

Brief Summary: 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.

Detailed Description: 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.