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Sponsored by: |
Xcyte Therapies |
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Information provided by: | Xcyte Therapies |
ClinicalTrials.gov Identifier: | NCT00048464 |
Patients will have immune cells collected and then expanded outside of the body. Patients will undergo standard treatment with high dose chemotherapy followed by peripheral blood stem cell transplantation. Three days following the transplant, patients will receive an infusion of a large number of expanded immune cells. The goal of the study will be to determine the safety as well as potential efficacy of this treatment.
Condition | Intervention | Phase |
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Multiple Myeloma |
Procedure: Infusion of Activated & Expanded Autologous T Cells |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of Xcellerated T Cells After Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Myeloma |
Estimated Enrollment: | 35 |
Study Start Date: | October 2002 |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Patient Inclusion Criteria
Patient Exclusion Criteria
United States, California | |
Cedars Sinai Medical Center | |
Los Angeles, California, United States, 90048 | |
University of California, San Francisco | |
San Francisco, California, United States, 94143 | |
University of California, San Diego | |
San Diego, California, United States, 92093 | |
United States, Maryland | |
Johns Hopkins Medical Institute | |
Baltimore, Maryland, United States, 21231 | |
United States, Missouri | |
Washington University | |
St. Louis, Missouri, United States, 63110 | |
United States, New Jersey | |
Hackensack University | |
Hackensack, New Jersey, United States, 07601 |
Study ID Numbers: | XT003 |
Study First Received: | October 31, 2002 |
Last Updated: | November 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00048464 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Immunotherapy T Cell Therapy Peripheral Blood Stem Cell Transplant |
Bone marrow transplant Adoptive immunotherapy Xcellerate |
Immunoproliferative Disorders Hemorrhagic Disorders Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders Vascular Diseases |
Paraproteinemias Lymphoproliferative Disorders Hemostatic Disorders Neoplasms, Plasma Cell Multiple Myeloma |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Blood Protein Disorders Hematologic Diseases Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |