Study to Evaluate the Safety and Clinical Activity of UCART123 in Patients With BPDCN
Phase 1
Terminated
- Conditions
- Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- Interventions
- Biological: UCART123
- 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
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
- Arm && Interventions
Group Intervention Description Part 1: Dose Escalation UCART123 A single intravenous administration of UCART123. Dose escalation in Part 1 will include 3 doses ranging from 6.25 x 10\^5 cells/kg to 6.25 x 10\^6 cells/kg and continue until the Recommended Phase 2 Dose (RP2D) is identified. Part 2: Dose Expansion UCART123 A single intravenous administration of UCART123 at the RP2D. 2 Cohorts: Patients with Relapsed/Refractory BPDCN and Newly Diagnosed BPDCN.
- Primary Outcome Measures
Name Time Method Incidence, nature, and severity of adverse events and serious adverse events Through day 84
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States