NCT03203369

Study to Evaluate the Safety and Clinical Activity of UCART123 in Patients With BPDCN

Phase 1, Open-label Dose-escalation and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of a Single Dose of UCART123 (Allogeneic Engineered T-cells Expressing Anti-CD123 Chimeric Antigen Receptor), Administered in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Cellectis S.A. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1 dose-finding study of Universal Chimeric Antigen Receptor T-cells targeting cluster of differentiation (CD) 123 (UCART123) administered intravenously to patients with relapsed or refractory Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), followed by a dose expansion phase in relapsed or refractory BPDCN patients or newly diagnosed BPDCN patients.

Conditions

• Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Interventions

Type	Name	Description
BIOLOGICAL	UCART123	Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor given as a single dose following a lymphodepleting regimen.

Timeline

• Start date: 2017-06-28
• Primary completion: 2019-06-27
• Completion: 2019-06-27
• First posted: 2017-06-29
• Last updated: 2019-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study