Refractory Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Phase I/II Study of Dual CD19-CD22 Chimeric Antigen Receptor (CAR) T Cells in Patients With Advanced CD19+ CD22+ Lymphoid Malignancies
This phase I/II trial studies the side effects and best dose of modified immune cells called CD19-CD22 chimeric antigen receptor (CAR) T cells in treating patients with CD19 positive(+), CD22+ B-acute lymphoblastic leukemia, chronic lymphocytic leukemia, or non-Hodgkin's lymphoma that has come back (recurrent) or does not respond to treatment (refractory). T-cells are collected from the patient and genetic materials called "chimeric antigen receptors (CAR)" are transferred to the collected T-cells. The CAR T-cells are then infused back to the patient's body. Giving CD19- CD22 CAR T cells after chemotherapy may help to control the disease.
PRIMARY OBJECTIVES: I. To determine the safety of infusion with chimeric antigen receptor T cells targeting CD19 and CD22. II. To find the recommended phase II dose for recurrent/refractory CD19+CD22+ B cell malignancies. SECONDARY OBJECTIVES: I. To describe the overall response rate and complete response rate of relapsed B cell malignancies treated with CAR-T cells targeting CD19 and CD22. II. To assess other response variables including minimal residual disease (MRD) negative remission, overall survival (OS), and event free survival (EFS). EXPLORATORY OBJECTIVES: I. To evaluate the immune reconstitution and persistence of CAR T cells for one year post infusion. OUTLINE: This is a phase I, dose escalation study of autologous CD19/CD22 chimeric antigen receptor T-cells (CD19-CD22 CAR T cells) followed by a phase II study. Patients receive standard of care cyclophosphamide intravenously (IV) over 30 minutes and fludarabine IV over 30 minutes on days -5, -4, and -3, and then receive CD19-CD22 CAR T cells IV on day 0. Patients with relapsed or persistent disease after a protocol assessment may receive a second infusion of CD19-CD22 CAR T cells. After completion of study treatment, patients are followed up at 1, 2, 3, 6, and 12 months. ;
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