NCT02743351

Study of ProTmune for Allogeneic HCT in Adult Patients With Hematologic Malignancies

A Phase 1, Non-Randomized, Open-Label/Phase 2, Randomized, Blinded Study of ProTmune™ (ex Vivo Programmed Mobilized Peripheral Blood Cells) Versus Non-Programmed Mobilized Peripheral Blood Cells for Allogeneic Hematopoietic Cell Transplantation in Adult Subjects With Hematologic Malignancies

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Fate Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase 1, non-randomized, open-label/Phase 2 randomized, blinded study of ProTmune (ex vivo programmed mobilized peripheral blood cells) versus non-programmed mobilized peripheral blood cells for allogeneic hematopoietic cell transplantation (HCT) in adult subjects aged 18 years and older with hematologic malignancies. A total of 88 study subjects were treated in the trial at approximately 15 centers in the US.

Conditions

• Hematologic Malignancies
• Acute Myeloid Leukemia
• Acute Lymphoblastic Leukemia
• Myelodysplastic Syndromes
• Chronic Myelogenous Leukemia
• Acute Graft-versus-host Disease

Interventions

Type	Name	Description
BIOLOGICAL	ProTmune	Ex-vivo, programmed mobilized peripheral blood (mPB) cells
BIOLOGICAL	Control Arm	Untreated mobilized peripheral blood (mPB) cells

Timeline

• Start date: 2016-12-20
• Primary completion: 2020-12-04
• Completion: 2021-11-05
• First posted: 2016-04-19
• Last updated: 2023-02-08
• Results posted: 2023-02-08

Locations

15 sites across 1 country: United States