NCT01527838

Single Treatment With FT1050 of an Ex-vivo Modulated Umbilical Cord Blood Unit

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Fate Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non-Hodgkin's Lymphoma (NHL)
• Hodgkin's Disease
• Chronic Lymphocytic Leukemia (CLL)
• Acute Myelogenous Leukemia (AML)
• Acute Lymphoblastic Leukemia (ALL)

Interventions

Type	Name	Description
BIOLOGICAL	Single FT1050 treated UCB unit	Ex-vivo CXCR4 upregulated hematopoietic progenitor cells, cord blood

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-10-01
• Completion: 2013-11-01
• First posted: 2012-02-07
• Last updated: 2016-09-12

Locations

3 sites across 1 country: United States