Acute Myeloid Leukaemia
Conditions
Keywords
Acute Myeloid Leukaemia, Newly diagnosed AML, ELN adverse genetic risk group, Chimeric Antigen Receptor T-Cell (CAR-T) therapy, Allogeneic, Transcription Activator-Like Effector Nuclease (TALEN)
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).
Interventions
BIOLOGICALUCART123
Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor
Sponsors
Cellectis S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed