Administration of Haploidentical Donor T Cells Transduced With the Inducible Caspase-9 Suicide Gene
If the patient is doing well after the stem cell transplant and does not have severe GvHD
s/he will be eligible to receive the special T cells from Day 30 to 90 after transplant. The
specially selected and treated T cells will be given by vein (IV) once.
This is a dose escalation study. This means that at the beginning, patients will be started
on the lowest dose (1 of 5 different levels) of T cells. Once that dose schedule proves
safe, the next group of patients will be started at a higher dose. This process will
continue all 5 dose levels are studied. If the side effects are too severe, the dose will be
lowered or the T cell injections will be stopped.
If the patient develops GvHD after being given the specially treated T cells, we will
prescribe AP1903, which has been shown to kill cells carrying the iCasp9 gene. This drug
will be given as a 2-hour IV infusion.
We will continue to follow the patient weekly in the bone marrow transplant clinic for the
first month after the infusion to check for side effects of the treatment and for GvHD. The
patient will have the standard tests performed that all patients have after transplant even
when not receiving special T cells.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical and Immunological effects of AP1903 administration
To evaluate the clinical and immunological effects of AP1903 administration, a dimerizer drug used to activate an iCaspase9 suicide gene mechanism, to subjects who have received escalating doses of T lymphocytes expressing the iCaspase9 gene and developed acute graft-versus-host-disease (GvHD).
Malcolm K Brenner, MB, PhD
Baylor College of Medicine
United States: Food and Drug Administration
|Texas Children's Hospital||Houston, Texas|
|The Methodist Hospital||Houston, Texas 77030|