NCT02354417

A Phase 1 Trial of a Single ProHema® CB Product for Pediatric Patients With Hematologic Malignancies

A Phase 1 Trial of a Single ProHema® CB Product (Ex Vivo Modulated Human Cord Blood Cells) Following Myeloablative Conditioning for Pediatric Patients With Hematologic Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Fate Therapeutics · Industry
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, safety study of a single ProHema-CB product administered following myeloablative conditioning regimen in pediatric subjects with hematologic malignancies.

Detailed description

A maximum of 18 eligible male and female subjects (1 to 18 years old, inclusive) will be enrolled and treated in the trial at approximately 3 to 5 centers within the U.S. These 18 subjects will consist of 3 cohorts of 6 subjects each. The cohorts will be defined by age: 1 to 4 years; \> 4 to 12 years; and \> 12 to 18 years. These cohorts will be enrolled simultaneously. All subjects will be admitted to the hospital, per institutional practice, and will receive a myeloablative conditioning regimen, after which they will receive an HLA-matched or partially matched ProHema-CB unit on study Day 0.

Conditions

• Hematologic Malignancies

Interventions

Type	Name	Description
BIOLOGICAL	Biological: ProHema-CB	Each subject will receive one administration of ProHema-CB unit transplant.

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-12-01
• Completion: 2017-02-01
• First posted: 2015-02-03
• Last updated: 2018-10-10
• Results posted: 2018-10-10

Locations

2 sites across 1 country: United States