CD19-Specific T-cells in Treating Patients With Advanced Lymphoid Malignancies

Summary

Participation Requirements

Description

PRIMARY OBJECTIVES: I. To determine the safety and maximum tolerated dose of genetically modified, CD19-specific T cells administered into patients with CD19+ advanced lymphoid malignancies. SECONDARY OBJECTIVES: I. To screen for the development of host immune responses against the CD19-specific chi...

PRIMARY OBJECTIVES: I. To determine the safety and maximum tolerated dose of genetically modified, CD19-specific T cells administered into patients with CD19+ advanced lymphoid malignancies. SECONDARY OBJECTIVES: I. To screen for the development of host immune responses against the CD19-specific chimeric antigen receptor (CAR). II. To describe the homing ability of the infused T cells. III. To assess disease response. IV. To determine persistence of CAR+ T cells. OUTLINE: This is a dose escalation study of CD19 positive chimeric antigen receptor T-cells. LYMPHODEPLETING CHEMOTHERAPY: Patients may receive standard chemotherapy comprised of fludarabine phosphate intravenously (IV) over 1 hour and cyclophosphamide IV over 3 hours on days -5 to -3 or cyclophosphamide IV every 12 hours on days -5 to -3 at the discretion of the treating physician. Within 30 days post completion of lymphodepletion, patients receive CD19 positive chimeric antigen receptor T-cells IV over 15-30 minutes on day 0, or split into two portions on days 0 and 1. After completion of study treatment, patients are followed up for at least 15 years.

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