drugset / Trial / NCT03301168

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

NCT03301168

Phase 1/2 Active not recruiting 120 enrolled Bellicum Pharmaceuticals
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2014-04
Primary completion
2021-05-11
Completion
2034-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Rimiducid Other / unclassified
Subject rivogenlecleucel Cell therapy