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

Acute Myeloid Leukaemia Clinical Trial

Official title:

Phase I, Open Label Dose-escalation Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of Multiple Infusions of UCART123 (Allogeneic Engineered T-cells Expressing Anti-CD123 Chimeric Antigen Receptor) in Patients With Adverse Genetic Risk Acute Myeloid Leukaemia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04106076
• Other study ID #: UCART123_03
• Status: Withdrawn
• Phase: Phase 1
• Start date: July 11, 2019
• Est. completion date: December 5, 2019

Study information

• Verified date: July 2020
• Source: Cellectis S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 5, 2019
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukaemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Biological:
• UCART123
Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cellectis S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of AE/SAE/DLT [Safety and Tolerability]	Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study	24 months