Last updated on November 2018

Patients are needed to participate in a clinical research study of Leukemia, Acute Myeloid (AML), Child, Acute myeloid leukemia, Immunodeficiency, MYELODYSPLASTIC SYNDROME, childhood ALL, Lymphoma, Preleukemia to evaluate AP1903

Brief description of study

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).

Detailed Study Description

This is a Phase 2 extension study evaluating the safety and feasibility of BPX-501 T cells infused after partially mismatched, related, TCR alpha beta T cell depleted hematopoietic stem cell transplant (HSCT) in pediatric patients. The purpose of this clinical trial is to determine whether BPX-501 infusion can enhance immune reconstitution in those patients with hematologic disorders, with the potential for reducing the severity and duration severe acute graft versus host disease (GvHD).

The trial will also evaluate the treatment of GvHD by the infusion of dimerizer drug (AP1903/rimiducid) in those subjects who present with GVHD who progress or do not respond to standard of care treatment.

Clinical Study Identifier: NCT02065869

Contact Investigators or Research Sites near you

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IRCCS Ospedale Pediatrico Bambino Ges
Roma, Italy

Unidad de Trasplante Hematopoy tico, Hospital Ni o Jes s
Madrid, Spain

Institute of Child Health & Great Ormond Street Hospital
London, United Kingdom

Great North Children's Hospital
Newcastle Upon Tyne, United Kingdom