Hodgkin's Disease Clinical Trial
Official title:
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
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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