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Study Evaluating Safety and Efficacy of UCART123 in Patients With Acute Myeloid Leukemia (AML123)

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ClinicalTrials.gov Identifier: NCT03190278
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Cellectis S.A.

Brief Summary:
Phase I, first-in-human, open-label, dose-finding study of UCART123 administered intravenously to patients with Acute Myeloid Leukemia (AML), followed by a dose escalation stage in relapsed or refractory AML patients and a dose-expansion stage in relapsed/refractory AML patients, and in poor-prognosis, newly diagnosed AML patients in the European LeukemiaNet (ELN) adverse genetic risk group.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Biological: UCART123 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I, Open Label Dose Escalation and Dose-Expansion Study to Evaluate the Safety, Expansion, Persistence, and Clinical Activity of a Single Dose of UCART123 (Allogeneic Engineered T-cells Expressing Anti-CD123 Chimeric Antigen Receptor), Administered in Patients With Relapsed/Refractory Acute Myeloid Leukemia, and Patients With Newly Diagnosed High-Risk Acute Myeloid Leukemia
Actual Study Start Date : June 19, 2017
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : December 15, 2021


Arm Intervention/treatment
Experimental: Part 1: Dose Escalation
One or two IV administrations of UCART123 in the dose escalation phase will explore 4 doses of UCART123 ranging from 1.25x10^5 cells/kg to 5.05x10^6 cells/kg and continue until the Maximum Tolerated Dose (MTD) is identified.
Biological: UCART123
Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor given following a lymphodepleting regimen

Experimental: Part 2: Dose Expansion
One or two IV administrations of UCART123. 2 Cohorts: Relapsed/Refractory AML, and in poor-prognosis, newly diagnosed AML patients in the ELN adverse genetic risk group.
Biological: UCART123
Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor given following a lymphodepleting regimen




Primary Outcome Measures :
  1. Incidence, nature, and severity of adverse events and serious adverse events [ Time Frame: Through Day 84(+/- 7 days), dose limiting toxicities are assessed during either 28 days or 42 days if patient experiences bone marrow aplasia at Day 28, after the initial UCART123 administration ]


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • AML adult patients expressing CD123
  • ECOG 0-1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03190278


Contacts
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Contact: Gabrielle Gosciniak (646) 962-9359 gag2663@med.cornell.edu
Contact: Aaron Logue, MBA 513-579-9911 ext 12889 a.logue@medpace.com

Locations
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United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Sponsors and Collaborators
Cellectis S.A.
Investigators
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Study Director: Cellectis S.A., MD Cellectis S.A.

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Responsible Party: Cellectis S.A.
ClinicalTrials.gov Identifier: NCT03190278     History of Changes
Other Study ID Numbers: UCART123_01
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cellectis S.A.:
Acute Myeloid Leukemia
Relapsed/Refractory Acute Myeloid Leukemia
Newly diagnosed AML
ELN adverse genetic risk group
Chimeric Antigen Receptor T-Cell (CAR-T) therapy
Allogeneic
Transcription Activator-Like Effector Nuclease (TALEN)
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms