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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study to evaluate the safety and efficacy of UCART123 in adults with high risk Acute Myeloid Leukaemia

Excerpt:
...Patients newly diagnosed with CD123 positive adverse genetic risk acute myeloid leukaemia (AML), including patients with CD123 positive AML secondary to MDS, who do not achieve complete remission, and whose bone marrow blast content is 50% as assessed by echocardiography; andv. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Go to data
Title:

Phase I Study of UCART123 in Patient With Adverse Genetic Risk Acute Myeloid Leukemia

Excerpt:
...- Patients newly diagnosed with CD123 positive adverse genetic risk acute myeloid leukaemia (AML) defined as per ELN guidelines (Döhner et al., 2017)...
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

94: AMELI-01: A Phase I Trial of UCART123v1.2, an Anti-CD123 Allogeneic CAR-T Cell Product, in Adult Patients with Relapsed or Refractory (R/R) CD123+ Acute Myeloid Leukemia (AML)

Published date:
05/02/2023
Excerpt:
AMELI-01 (NCT04106076) is a phase 1 trial evaluating the safety, tolerability, expansion, and persistence of UCART123 given at escalating dose levels after LD with either fludarabine and cyclophosphamide...Evidence of UCART123 activity was observed in 4/16 pts with best overall responses as follows: FC arm (DL2: 1 SD; DL2i: 1 MLFS); FCA arm (DL2: 1 SD and 1 MRD-negative CR)....Overall, these data support the safety and activity of UCART123 after FCA LD in pts with CD123+ R/R AML.
Trial ID: