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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
BMT Program at Northside Hospital
Atlanta, Georgia, United States
University of Kansas
Westwood, Kansas, United States
Roswell Park
Buffalo, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
UT Southwestern Medical Center
Dallas, Texas, United States
BPX-501 Safety
To evaluate the safety of 2 stratified dose levels of BPX-501 T cell infusions based on patient-donor match in adult subjects with hematological malignancies
Time frame: Month 24
Rimiducid Safety
evaluate the safety of the infusion of escalating doses of dimerizer drug rimiducid (AP1903) in subjects who develop acute GvHD after BPX-501 infusion
Time frame: Month 24
GvHD
Assess incidence and severity of acute and chronic GvHD
Time frame: Month 24
Rimiducid Activity
Determine the effect of Rimiducid on mitigating GvHD
Time frame: Month 24
Rimiducid Efficacy
Assess time to resolution of GvHD after administration of Rimiducid
Time frame: Month 24
Response Rate
Measure overall survival, disease free survival and response rates after BPX-501 infusion
Time frame: Month 24
Translational
Evaluate BPX-501 T cell function
Time frame: Month 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.