Allo CART-19 Protocol
The primary objective is to determine the safety and survival of the redirected allogeneic T cells transduced with the anti-CD19 lentiviral vector (referred to as CART-19 cells).
Abramson Cancer Center of the University of Pennsylvania has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of Donor Lymphocyte Infusions Using Donor T Cells Engineered to Contain Anti-CD19 Attached To TCR And 4-1BB Signaling Domains in Patients With Relapsed CD19+ All After Allogeneic Stem Cell Transplantation|
- Number of Adverse Events [ Designated as safety issue: Yes ]
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
The investigators propose an open label, single center, pilot study to evaluate the safety and tolerability, and persistence of donor lymphocytes engineered to express a chimeric antigen receptor targeting CD19 which is linked to the CD3:4-1BB signaling chains in patients with CD19+ acute lymphoblastic leukemia (ALL). Upon enrollment, donors will undergo leukapheresis and patients will undergo an optional bone marrow/lymph node biopsy approximately four weeks prior to dosing. Between dosing and treatment, patients may undergo an additional chemotherapy treatment depending upon their disease. At dosing, patients will receive redirected donor lymphocytes targeted against CD19 (allo-CART-19 cells). The cell dose will be given as a split infusion over three days to enhance the ability to manage any infusion related toxicity. Patients will be monitored weekly for four weeks. At the end of four weeks, patients will undergo a second leukapheresis and second optional bone marrow/lymph node biopsy. At this point the patient will also undergo restaging. Observation and monitoring of patients will continue on a monthly basis until week 24 post dosing. Annual follow-up for lentiviral vector safety will be carried out for 15 years in accordance with FDA guidelines for retroviral vectors. Ten subjects will be targeted for this study, with an expected rate of drop out of 30% due to disease progression between enrollment and week four post dosing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551043
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||David Porter, MD||Abramson Cancer Center of the University of Pennsylvania|