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Study of Gene Modified Donor T-cells Following TCR Alpha Beta Positive Depleted Stem Cell Transplant
Sponsor: Bellicum Pharmaceuticals
Summary
This study will evaluate pediatric patients with malignant or non-malignant blood cell disorders who are having a blood stem cell transplant depleted of T cell receptor (TCR) alfa and beta cells that comes from a partially matched family donor. The study will assess whether immune cells, called T cells, from the family donor, that are specially grown in the laboratory and given back to the patient along with the stem cell transplant can help the immune system recover faster after transplant. As a safety measure these T cells have been programmed with a self-destruct switch so that they can be destroyed if they start to react against tissues (graft versus host disease).
Official title: Phase I/II Study of CaspaCIDe® T Cells From an HLA-Partially Matched Family Donor After Negative Selection of TCR αβ+T Cells in Pediatric Patients Affected by Hematological Disorders
Key Details
Gender
All
Age Range
1 Month - 26 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2014-04
Completion Date
2034-05
Last Updated
2022-07-12
Healthy Volunteers
No
Conditions
Interventions
BPX-501 T cells
T cells transduced with CaspaCIDe® safety switch
Rimiducid
administered to inactivate BPX-501 cells in the event of GVHD
Locations (10)
Children's Hospital Los Angeles
Los Angeles, California, United States
Stanford University - Division of Pediatric Stem Cell Transplant & Regenerative Medicine
Palo Alto, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Dana-Farber Boston Children's Cancer and Blood Disorders Center
Boston, Massachusetts, United States
Children's Hospital at Montefiore
The Bronx, New York, United States
Oregon Health Sciences University - Doernbecher Children's Hospital
Portland, Oregon, United States
University of Texas Southwestern-Children's Medical Center
Dallas, Texas, United States
Baylor College of Medicine/ Texas Children's Hospital
Houston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States