Clinical trial · Interventional
Phase I Study of UCART123 in Patient With Adverse Genetic Risk Acute Myeloid Leukemia
Phase I, Open Label Dose-escalation Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of Multiple Infusions of UCART123 (Allogeneic Engineered T-cells Expressing Anti-CD123 Chimeric Antigen Receptor) in Patients With Adverse Genetic Risk Acute Myeloid Leukaemia
- 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)
This is a Phase I, open-label, dose escalation study of UCART123 administered intravenously to patients with newly diagnosed CD123 positive adverse genetic risk acute myeloid leukaemia (AML) defined in the ELN adverse genetic risk group (2017). The purpose of this study is to evaluate the safety and clinical activity of multiple infusions of UCART123 and to determine the Maximum Tolerated Dose (MTD).
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 |
|---|---|---|---|
| Acute Myeloid Leukaemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| UCART123 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose escalation
- description
- Several tested doses of UCART123 until the Maximum Tolerated Dose (MTD) is identified.
- interventionNames
- Biological: UCART123
Primary outcomes (1)
- measure
- Incidence of AE/SAE/DLT [Safety and Tolerability]
- timeFrame
- 24 months
- description
- Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Main Inclusion Criteria: * Patients newly diagnosed with CD123 positive adverse genetic risk acute myeloid leukaemia (AML) defined as per ELN guidelines (Döhner et al., 2017) * Eastern Cooperative Oncology Group performance status of 0 or 1 * No prior gene or experimental cellular therapy * No organ dysfunction that in the opinion of the investigator precludes intensive induction chemotherapy or cellular therapy
References
Publications (0)
Data not yet available