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

Phase 1TerminatedNCT03203369

Cellectis S.A.1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Interventions

UCART123BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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;

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Incidence, nature, and severity of adverse events and serious adverse events

Time frame: Through day 84

Data from ClinicalTrials.gov

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