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ACTIVE NOT RECRUITING
NCT03301168
PHASE1/PHASE2

Study of Gene Modified Donor T-cells Following TCR Alpha Beta Positive Depleted Stem Cell Transplant

Sponsor: Bellicum Pharmaceuticals

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

BPX-501 T cells

T cells transduced with CaspaCIDe® safety switch

DRUG

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