Trial ID:NCT03190278
Protocol #:18-233
Condition(s):Relapsed/Refractory Acute Myeloid Leukemia
Phase:I
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