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

NCT04106076

Description:

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).

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Withdrawn

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Phase I Dose-Escalation Study of UCART123 in Patient With Adverse Genetic Risk Acute Myeloid Leukemia
  • 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 IDs

  • ORG STUDY ID: UCART123_03
  • NCT ID: NCT04106076

Conditions

  • Acute Myeloid Leukaemia

Interventions

DrugSynonymsArms
UCART123Dose escalation

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Dose escalationExperimentalSeveral tested doses of UCART123 until the Maximum Tolerated Dose (MTD) is identified.
  • UCART123

Eligibility 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
      
Maximum Eligible Age:65 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety of UCART123
Time Frame:24 months
Safety Issue:
Description:Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Cellectis S.A.

Trial 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)

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