Last updated on February 2018

A Study of CD19 Redirected Autologous T Cells for CD19 Positive Systemic Lupus Erythematosus (SLE)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Age: Between 18 - 69 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Clinical diagnosis of systemic lupus erythematosus (SLE) patients
  • Patients with CD19+ B-cell SLE as confirmed by Flow Cytometry
  • Age: 18-69 years old
  • Creatinine < 1.5 mg/dl
  • cardiac ejection fraction55%
  • hemoglobin>9g/dL
  • Bilirubin <2.0 mg/dl
  • Successful test expansion of T-cells
  • Adequate venous access for apheresis, and no other contraindications for leukapheresis
  • Voluntary informed consent is given

Exclusion Criteria:

  • Pregnant or lactating women
  • Uncontrolled active infection
  • Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
  • Previously treatment with any gene therapy products
  • Feasibility assessment during screening demonstrates<5% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation
  • Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, serious arrhythmia)

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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