A Phase I study of BPX-501 T cell infusion in adults with recurrent or minimal residual
disease (MRD) hematologic malignancies post-allogeneic transplant. The treatment consists
of increasing doses of BPX-501 T cell infusions to achieve a clinical response. Rimiducid
will be investigated for the treatment of aGvHD after BPX-501 T cell infusion to
determine a dose that can mitigate GvHD and preserve the graft versus leukemia effect.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02477878.
Unmanipulated donor lymphocyte infusion (DLI) is used after stem cell transplantation to
treat and prevent relapse, to prevent infections and to establish full donor chimerism.
The addition of mature T cells which exhibit a broad repertoire of T cell immunity
against viral and cancer antigens, might provide a clinical benefit. However, an expected
side effect of the presence of mature T cells is the potential occurrence of acute
graft-versus-host disease (aGVHD). BPX-501 contains genetically modified donor T cells
that have an inducible safety switch iCasp9 suicide gene. Evidence has emerged that
escalating DLI has achieved higher clinical response rate with lower GVHD occurrence.
Optimization of DLI dose and schedule as well as strategies of donor T-cell manipulation
may lead to the consistent ability to separate GVHD from GvL (graft-versus-leukemia)
activity and improve the safety of DLI treatment.
Lead OrganizationBellicum Pharmaceuticals
