A Phase I/II Study of Xcellerated T Cells After Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Myeloma
This Phase I/II clinical study is designed to examine the safety of Xcellerated T Cells, an
activated, autologous T cell product, in study subjects undergoing an autologous peripheral
blood stem cell transplant for the treatment of multiple myeloma. Thirty-five patients will
be treated. Patients must have undergone induction therapy prior to study registration, and
may not have progressed following induction therapy or any other prior therapy for myeloma.
Patients will undergo a steady state leukapheresis (Xcellerate Leukapheresis) to obtain
peripheral blood mononuclear cells that will be used to produce Xcellerated T Cells. During
the Xcellerate Process, T cells will be activated and expanded ex vivo by co-stimulation
with anti-CD3 and anti-CD28 monoclonal antibodies covalently attached to super-paramagnetic
microbeads. While the Xcellerated T Cells are being produced at Xcyte Therapies, patients
will be treated with a standard mobilization regimen consisting of cyclophosphamide and
filgrastim (Neupogen; G-CSF), followed by a second leukapheresis for collection of
peripheral blood stem cells. Patients will be treated with a standard high-dose
chemotherapy regimen for multiple myeloma consisting of single agent melphalan (200mg/m2).
Patients will then receive their peripheral blood stem cells followed by post-transplant
filgrastim for neutrophil recovery. Three days (Day 3) following stem cell infusion,
patients will receive a single dose Xcellerated T Cells.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
XT003
NCT00048464
October 2002
Name | Location |
---|---|
Cedars Sinai Medical Center | Los Angeles, California 90048-1804 |
University of California, San Francisco | San Francisco, California 94143 |
Washington University | St. Louis, Missouri 63110 |
University of California, San Diego | La Jolla, California 92037-1709 |
Johns Hopkins Medical Institute | Baltimore, Maryland 21231 |
Hackensack University | Hackensack, New Jersey 07601 |