Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The trial was discontinued due to sponsor's decision and not a consequence of any safety concern.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) | Blastic Plasmacytoid Dendritic Cell Neoplasm | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| UCART123 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1: Dose Escalation
- description
- 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.
- interventionNames
- Biological: UCART123
- type
- EXPERIMENTAL
- label
- Part 2: Dose Expansion
- description
- A single intravenous administration of UCART123 at the RP2D. 2 Cohorts: Patients with Relapsed/Refractory BPDCN and Newly Diagnosed BPDCN.
- interventionNames
- Biological: UCART123
Primary outcomes (1)
- measure
- Incidence, nature, and severity of adverse events and serious adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available