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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03203369

Acronym

ABC123

Enrollment

Registered

2017-06-29

Start date

2017-06-28

Completion date

2019-06-27

Last updated

2019-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Keywords

Blastic plasmacytoid dendritic cell neoplasm, Natural Killer (NK) cell blastic lymphoma, Hematologic malignancies, Cluster of differentiation (CD) CD4+CD56+ hematodermic tumor, Acute leukemia and myeloid neoplasms, Chimeric Antigen Receptor T-cell (CAR-T) therapy, Allogeneic, Cluster of differentiation 4 (CD4), Cluster of differentiation 56 (CD56)

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.

Interventions

BIOLOGICALUCART123

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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;

Design outcomes

Primary

Measure	Time frame
Incidence, nature, and severity of adverse events and serious adverse events	Through day 84

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026