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NCT03190278Active, not recruitingPhase 1

Study Evaluating Safety and Efficacy of UCART123v1.2 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

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

Source: ClinicalTrials.gov · Last updated 7 Aug 2025

Brief summary (registry, in English)

Phase I, open-label, dose-escalation and dose-expansion study evaluating the safety and efficacy of Universal Chimeric Antigen Receptor T-cell (UCART) targeting the Cluster of Differentiation 123 (CD123) in patients with relapsed/refractory acute myeloid leukemia (AML). The purpose of this study is to evaluate the safety and clinical activity of Universal Chimeric Antigen Receptor T-cells targeting CD123 (UCART123v1.2) and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
29 (actual)
First submitted
14 Jun 2017
Start date
19 Jun 2017
Primary completion date
24 Dec 2024
Lead sponsor
Cellectis S.A.
NCT number
NCT03190278

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 29
  • From 19 Jun 2017 to the primary completion date, 24 Dec 2024
  • 8 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • Main Inclusion Criteria:
  • Patients with relapsed or primary refractory AML (as defined in World Health Organization \[WHO\] criteria) with ≥5% bone marrow blasts
  • Patients with CD123+ blast cells (verified by flow cytometry)
  • Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of ≤1
  • Adequate organ function, including bone marrow, renal, hepatic, pulmonary, and cardiac function based on the last assessment performed within screening period
  • (Dose-escalation) Identified donor and transplant strategy prior to lymphodepletion (LD)
  • Other criteria may apply
    • Main Exclusion Criteria:
  • Patients with acute promyelocytic leukemia (APL) or central nervous system (CNS) Leukemia
  • Previous investigation gene or cell therapy (including CAR)
  • \> 1 prior allogeneic stem cell transplantations (SCTs)
  • Prior treatment with rituximab or other anti-cluster of differentiation 20 (anti-CD20) therapy within 3 months
  • Any known active or uncontrolled infection
  • Other criteria may apply

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dana-Farber Cancer Institute
Coordinator of this site? Confirm its status		BostonUnited StatesUnknown status
Roswell Park Cancer Institute
Coordinator of this site? Confirm its status		BuffaloUnited StatesUnknown status
Northwestern University
Coordinator of this site? Confirm its status		ChicagoUnited StatesUnknown status
MD Anderson Cancer Center
Coordinator of this site? Confirm its status		HoustonUnited StatesUnknown status
Weill Medical College of Cornell University
Coordinator of this site? Confirm its status		New YorkUnited StatesUnknown status
University of Pennsylvania/Abramson Cancer Center
Coordinator of this site? Confirm its status		PhiladelphiaUnited StatesUnknown status
University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
Coordinator of this site? Confirm its status		San FranciscoUnited StatesUnknown status
H Lee Moffitt Cancer Center & Research Institute
Coordinator of this site? Confirm its status		TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.