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| Sponsor: | Xcyte Therapies |
|---|---|
| Information provided by: | Xcyte Therapies |
| ClinicalTrials.gov Identifier: | NCT00048464 |
Purpose
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 |
|---|---|---|
|
Multiple Myeloma |
Procedure: Infusion of Activated & Expanded Autologous T Cells |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Patient Inclusion Criteria
Patient Exclusion Criteria
Contacts and Locations| United States, California | |
| Cedars Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| University of California, San Diego | |
| San Diego, California, United States, 92093 | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94143 | |
| 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 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00048464 History of Changes |
| Other Study ID Numbers: | XT003 |
| Study First Received: | October 31, 2002 |
| Last Updated: | November 6, 2006 |
| Health Authority: | United States: Food and Drug Administration |
|
Immunotherapy T Cell Therapy Peripheral Blood Stem Cell Transplant |
Bone marrow transplant Adoptive immunotherapy Xcellerate |
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |