This trial is a prospective, open-label, single-arm trial of the safety of a single FT1050-treated CB unit for hematopoietic reconstitution after a reduced-intensity conditioning regimen for hematologic malignancies. A maximum of 40 eligible adult subjects will be enrolled and treated in the trial at approximately 2-4 centers within the U.S.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Ex-vivo CXCR4 upregulated hematopoietic progenitor cells, cord blood
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute-Hematopoietic Stem Cell Transplant Program
Boston, Massachusetts, United States
Ohio State Univeristy Comprehensive Cancer Center
Columbus, Ohio, United States
Neutrophil engraftment/chimerism
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.
Time frame: Day 42
Safety
Define the safety profile of treatment with a single FT1050-treated CB unit. To define the preliminary efficacy of treatment with a single FT1050-treated CB unit.
Time frame: Day 100
Immune reconstitution
To assess immune reconstitution (B-, T-, and NK-cells).
Time frame: 2 years
Donor search
To determine time from the initiation of donor search to transplantation.
Time frame: Day 0
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