For Healthcare Professionals

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


About the study

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).

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Main Inclusion Criteria:

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


Main Exclusion Criteria:

  1. Patients with APL or CNS Leukemia
  2. Previous investigation gene or cell therapy (including CAR)
  3. ≥ 2 prior allogeneic SCTs
  4. Prior treatment with rituximab or other anti-CD20 therapy within 3 months
  5. Any known active or uncontrolled infection
  6. Other criteria may apply
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Relapsed/Refractory Acute Myeloid Leukemia

Age (in years)

18 - 65


Phase 1

Participants needed


Est. Completion Date

Mar 31, 2023

Treatment type



Cellectis S.A. identifier


Study number


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