Clinical trial · Interventional
Study Evaluating Safety and Efficacy of UCART123v1.2 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Phase I, Open Label Dose Escalation and Dose-Expansion Study to Evaluate the Safety, Expansion, Persistence, and Clinical Activity of UCART123 (Allogeneic Engineered T-cells Expressing Anti-CD123 Chimeric Antigen Receptor), Administered in Patients With Relapsed/Refractory Acute Myeloid Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase I, open-label, dose-escalation and dose-expansion study evaluating the safety and efficacy of Universal Chimeric Antigen Receptor T-cell (UCART) targeting the Cluster of Differentiation 123 (CD123) in patients with relapsed/refractory acute myeloid leukemia (AML). The purpose of this study is to evaluate the safety and clinical activity of Universal Chimeric Antigen Receptor T-cells targeting CD123 (UCART123v1.2) and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).
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 |
|---|---|---|---|
| Relapsed/Refractory Acute Myeloid Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| UCART123v1.2 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- UCART123v1.2 tested at several dose levels with different lymphodepletion regimens to establish Maximum Tolerated Dose (MTD) and identify Recommended Phase 2 Dose (RP2D) Dose Expansion: UCART123v1.2 administered at the RP2D determined from the dose escalation phase
- interventionNames
- Biological: UCART123v1.2
Primary outcomes (2)
- measure
- Incidence of adverse events (AE)/serious adverse events (SAE)/Dose Limiting Toxicities (DLT) [Safety and Tolerability]
- timeFrame
- 24 Months
- description
- Safety of UCART123v1.2 - Incidence, nature, and severity of AE and SAEs throughout the study
- measure
- Dose escalation and expansion part: Occurrence of DLTs
- timeFrame
- Up to Day 28 post last UCART123v1.2 infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Main Inclusion Criteria: * Patients with relapsed or primary refractory AML (as defined in World Health Organization \[WHO\] criteria) with ≥5% bone marrow blasts * Patients with CD123+ blast cells (verified by flow cytometry) * Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of ≤1 * Adequate organ function, including bone marrow, renal, hepatic, pulmonary, and cardiac function based on the last assessment performed within screening period * (Dose-escalation) Identified donor and transplant strategy prior to lymphodepletion (LD) * Other criteria may apply Main Exclusion Criteria: * Patients with acute promyelocytic leukemia (APL) or central nervous system (CNS) Leukemia * Previous investigation gene or cell therapy (including CAR) * \> 1 prior allogeneic stem cell transplantations (SCTs) * Prior treatment with rituximab or other anti-cluster of differentiation 20 (anti-CD20) therapy within 3 months * Any known active or uncontrolled infection * Other criteria may apply
References
Publications (0)
Data not yet available