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

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Clinical Trial

— ABC123  

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03203369
• Other study ID #: UCART123_02
• Status: Terminated
• Phase: Phase 1
• Start date: June 28, 2017
• Est. completion date: June 27, 2019

Study information

• Verified date: July 2019
• Source: Cellectis S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 27, 2019
• Est. primary completion date: June 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Main 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;

Related Conditions & MeSH terms

• Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
• Neoplasms

Intervention

Biological:
• UCART123
Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor given as a single dose following a lymphodepleting regimen.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Cellectis S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence, nature, and severity of adverse events and serious adverse events		Through day 84