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).
Withdrawn
Phase 1
| Drug | Synonyms | Arms |
|---|---|---|
| UCART123 | Dose escalation |
| Name | Type | Description | Interventions |
|---|---|---|---|
| Dose escalation | Experimental | Several tested doses of UCART123 until the Maximum Tolerated Dose (MTD) is identified. |
|
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
| Maximum Eligible Age: | 65 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Incidence of AE/SAE/DLT [Safety and Tolerability] |
| Time Frame: | 24 months |
| Safety Issue: | |
| Description: | Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study |
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Withdrawn |
| Lead Sponsor: | Cellectis S.A. |
July 14, 2020
