drugset / Trial / NCT02065869

Safety Study of Gene Modified Donor T-cells Following TCRαβ+ Depleted Stem Cell Transplant

NCT02065869

Phase 1/2 Terminated 187 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
2020-06
Completion
2021-09-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Rimiducid Other / unclassified 0.4 mg/kg Intravenous
Subject rivogenlecleucel Cell therapy 1e+06 cells/kg