A Phase I Trial of a Single FT1050 (16,16-Dimethyl Prostaglandin E2) Ex Vivo-Modulated Umbilical Cord Blood (CB) Unit Following a Reduced Intensity Conditioning Regimen For Adults With Hematologic Malignancies
The trial will be conducted in three sequential cohorts of 6-12 evaluable subjects each.
Cohort 1 will enroll eligible subjects for whom a single CB unit has been identified that
meets the minimum HLA-matching criteria and has a minimum pre-cryopreservation total
nucleated cell (TNC) dose of at least 2.5 x 10^7 cells/kg. Cohort 2 is identical to Cohort
1, except that the TNC dose of the CB unit must be between 2.0 - <2.5 x 10^7 cells/kg.
Finally, Cohort 3 is identical to Cohort 2, except that the TNC dose of the CB unit must be
between 1.5 - <2.0 x 10^7 cells/kg. If no safety rules are triggered, the study will
proceed to the next dosing cohort. Within a dosing cohort, no more than three subjects may
be before Day 42 at any one time, unless they have already engrafted neutrophils. The final
dosing cohort is defined as the last cohort where 12 evaluable subjects are treated and no
stopping rules are triggered. The corresponding TNC dose level will be considered the
minimally acceptable TNC dose level.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the minimally effective TNC dose for a single FT1050-treated CB unit based on neutrophil engraftment/chimerism when used for hematopoietic reconstitution following a reduced-intensity conditioning regimen for hematologic malignancies.
Pratik Multani, MD
United States: Food and Drug Administration
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Dana Farber Cancer Institute-Hematopoietic Stem Cell Transplant Program||Boston, Massachusetts 02215|
|Ohio State Univeristy Comprehensive Cancer Center||Columbus, Ohio 43210|