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

Cellectis

Status and phase: Withdrawn; Phase 1

Conditions: Acute Myeloid Leukaemia

Treatments: Biological: UCART123

Study type: Interventional

Funder types: Industry

Identifiers

NCT04106076

UCART123_03

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Dose escalation

Experimental group

Description:

Several tested doses of UCART123 until the Maximum Tolerated Dose (MTD) is identified.

Treatment:

Biological: UCART123