Study of Gene Modified Donor T Cell Infusion in Patients With Recurrent Disease After Allogeneic Transplant
Condition(s) studied
Investigational drug(s) / intervention(s)
BPX-501: Biological: T cells transduced with CaspaCIDe suicide gene
Rimiducid: Rimiducid administered to treat GVHD
Study summary
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.
Eligibility
Primary outcome measure(s)
- BPX-501 Safety — Month 24
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 - Rimiducid Safety — Month 24
evaluate the safety of the infusion of escalating doses of dimerizer drug rimiducid (AP1903) in subjects who develop acute GvHD after BPX-501 infusion - GvHD — Month 24
Assess incidence and severity of acute and chronic GvHD - Rimiducid Activity — Month 24
Determine the effect of Rimiducid on mitigating GvHD - Rimiducid Efficacy — Month 24
Assess time to resolution of GvHD after administration of Rimiducid
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| BMT Program at Northside Hospital | Atlanta | Georgia | |
| University of Kansas | Westwood | Kansas | |
| Roswell Park | Buffalo | New York | |
| Oregon Health & Science University | Portland | Oregon | |
| UT Southwestern Medical Center | Dallas | Texas |
More Bellicum Pharmaceuticals trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02477878 on ClinicalTrials.gov ↗ ← All trials in the USA