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:
INCLUSION CRITERIA
Main 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)
- 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
EXCLUSION CRITERIA
Main 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
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
Contition
Relapsed/Refractory Acute Myeloid Leukemia
Age (in years)
18 - 65
Phase
Phase 1
Participants needed
65
Est. Completion Date
Mar 31, 2023
Treatment type
Interventional
Sponsor
Cellectis S.A.
ClinicalTrials.gov identifier
NCT03190278
Study number
UCART123_01
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