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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

Not Enrolling

Trial ID:NCT03190278

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Protocol #:18-233

877-DF-TRIAL (877-338-7425)

Condition(s):Relapsed/Refractory Acute Myeloid Leukemia


Principal Investigator:DeAngelo, Daniel, J

Site Research Nurse(s):Toomey-Mathews, Ellen,

Trial Description:
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).

Eligibility Requirements:
Main - 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
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

Protocol #: 18-233

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