Phase I Study of UCART123 in Patient With Adverse Genetic Risk Acute Myeloid Leukemia

Cellectis S.A.

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Acute Myeloid Leukaemia

Interventions

UCART123BIOLOGICAL

Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of AE/SAE/DLT [Safety and Tolerability]

Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study

Time frame: 24 months

Data from ClinicalTrials.gov

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