The purpose of this Phase 1, first in human open-label study is to assess the safety and tolerability of TRX-103 in patients with hematological malignancies undergoing HLA-mismatched related or unrelated hematopoietic stem cell transplantation (HSCT). It is anticipated that up to 36 Subjects will be enrolled during a 18-24 month enrollment period. TRX-103 will be infused one time post HSCT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
36
TRX103 infusion via central line.
City of Hope
Duarte, California, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGUniversity of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGFred Hutchinson Cancer Center
Seattle, Washington, United States
RECRUITINGSafety and tolerability of TRX103 cell infusion through incidence of Adverse events.
Time frame: Up to a year
Safety of TRX103 determined by stem cell engraftment and donor chimerism after HSCT measured by absolute neutrophil counts and percent donor chimerism.
Time frame: Up to day 42
Safety of TRX103 determined by negative Replication Competent Lentivirus (RCL).
Time frame: At 3-month, 6-month, and 1-year.
Incidence of Grade II-IV acute GvHD (aGvHD).
Time frame: Day 0 to Day +100 day
Incidence of Grade III-IV acute GvHD (aGvHD).
Time frame: Day 0 to Day +100 day
Incidence and severity of chronic GvHD (cGvHD)
Time frame: Day +100 through Day +365
Overall survival at Day +365.
Time frame: Up to a year
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