Acute Myeloid Leukemia Clinical Trial

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

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).

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

65

Study ID:

NCT03190278

Recruitment Status:

Recruiting

Sponsor:

Cellectis S.A.

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There are 9 Locations for this study

See Locations Near You

University of California, San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94143, United States
Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa Florida, 33612, United States
Northwestern University
Chicago Illinois, 60201, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Weill Medical College of Cornell University
New York New York, 10021, United States
University of Pennsylvania - Abramson Cancer Center
Philadelphia Pennsylvania, 19104, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

65

Study ID:

NCT03190278

Recruitment Status:

Recruiting

Sponsor:


Cellectis S.A.

How clear is this clinincal trial information?

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