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

Phase 1

Terminated

• Conditions: Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

• Registration Number: NCT03203369
• Lead Sponsor: Cellectis S.A.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-14
• Study Start: 2017-06-28
• Study First Submitted QC: 2017-06-28
• Study First Posted: 2017-06-29
• Primary Completion: 2019-06-27
• Study Completion: 2019-06-27
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Patients with a diagnosis BPDCN according to World Health Organization (WHO) classification confirmed by hematopathology;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence, nature, and severity of adverse events and serious adverse events	Through day 84

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States