Study Evaluating Safety and Efficacy of UCART123 in Patients With Relapsed/ Refractory Acute Myeloid Leukemia (AMELI-01)

  • STATUS
    Recruiting
  • End date
    Mar 13, 2023
  • participants needed
    65
  • sponsor
    Cellectis S.A.
Updated on 13 June 2022
flow cytometry
refractory acute myeloid leukemia (aml)
blast cells

Summary

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 UCART123v1.2 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).

Details
Condition Relapsed/Refractory Acute Myeloid Leukemia
Treatment UCART123, UCART123v1.2
Clinical Study IdentifierNCT03190278
SponsorCellectis S.A.
Last Modified on13 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with relapsed or primary refractory AML (as defined in WHO criteria) with >5% bone marrow blasts
Patients with CD123+ blast cells (verified by flow cytometry)
Adequate organ function, including bone marrow, renal, hepatic, pulmonary, and cardiac function based on the last assessment performed within screening period
Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of ≤1
Other criteria may apply
(Dose-escalation) Identified donor and transplant strategy prior to lymphodepletion (LD)

Exclusion Criteria

Patients with APL or CNS Leukemia
Previous investigation gene or cell therapy (including CAR)
≥ 2 prior allogeneic SCTs
Prior treatment with rituximab or other anti-CD20 therapy within 3 months
Any known active or uncontrolled infection
Other criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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