Phase I Study of UCART123 in Patient With Adverse Genetic Risk Acute Myeloid Leukemia
Phase 1
Withdrawn
- Conditions
- Acute Myeloid Leukaemia
- Interventions
- Biological: UCART123
- Registration Number
- NCT04106076
- Lead Sponsor
- Cellectis S.A.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose escalation UCART123 Several tested doses of UCART123 until the Maximum Tolerated Dose (MTD) is identified.
- Primary Outcome Measures
Name Time Method Incidence of AE/SAE/DLT [Safety and Tolerability] 24 months Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study
- Secondary Outcome Measures
Name Time Method