Clinical Trials /

Study Evaluating Safety and Efficacy of UCART123 in Patients With Relapsed/ Refractory Acute Myeloid Leukemia

NCT03190278

Description:

Phase I, first-in-human, open-label, dose-escalation and dose-expansion study evaluating the safety and efficacy of UCART targeting CD123 in patients with relapsed/refractory acute myeloid leukemia (AML). The purpose of this study is to evaluate the safety and clinical activity of one infusion of UCART123 and determine the Maximum Tolerated Dose (MTD).

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study Evaluating Safety and Efficacy of UCART123 in Patients With Relapsed/ Refractory Acute Myeloid Leukemia
  • Official Title: Phase I, Open Label Dose Escalation and Dose-Expansion Study to Evaluate the Safety, Expansion, Persistence, and Clinical Activity of UCART123 (Allogeneic Engineered T-cells Expressing Anti-CD123 Chimeric Antigen Receptor), Administered in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Clinical Trial IDs

  • ORG STUDY ID: UCART123_01
  • NCT ID: NCT03190278

Conditions

  • Relapsed/Refractory Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
UCART123Part 1: Dose Escalation

Purpose

Phase I, first-in-human, open-label, dose-escalation and dose-expansion study evaluating the safety and efficacy of UCART targeting CD123 in patients with relapsed/refractory acute myeloid leukemia (AML). The purpose of this study is to evaluate the safety and clinical activity of one infusion of UCART123 and determine the Maximum Tolerated Dose (MTD).

Trial Arms

NameTypeDescriptionInterventions
Part 1: Dose EscalationExperimentalSeveral tested doses of UCART123 until the Maximum Tolerated Dose (MTD) is identified Dose Expansion: UCART123 administered at the selected dose determined from the dose escalation phase
  • UCART123

Eligibility Criteria

        Main Inclusion Criteria:

          -  Patients with relapsed or primary refractory AML (as defined in WHO criteria) with >5%
             bone marrow blasts

          -  Eastern Cooperative Oncology Group Performance Status of 0 or 1

          -  Adequate organ function, including bone marrow, renal, hepatic, pulmonary, and cardiac
             function based on the last assessment performed within screening period

          -  Other criteria may apply
      
Maximum Eligible Age:64 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of AE/SAE/DLT [Safety and Tolerability]
Time Frame:24 Months
Safety Issue:
Description:Safety of UCART123 - 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 Leukemia
  • Relapsed/Refractory Acute Myeloid Leukemia
  • Chimeric Antigen Receptor T-Cell (CAR-T) therapy
  • Allogeneic
  • Transcription Activator-Like Effector Nuclease (TALEN)

Last Updated

December 4, 2019