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
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Adverse Events
Yes
David Porter, MD
Principal Investigator
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
UPCC 01410
NCT01551043
September 2010
September 2013
Name | Location |
---|---|
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |