This is a phase I/2, interventional, open-label, multicenter study to assess the safety and efficacy of ARD103 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.
Documented diagnosis of AML with either refractory or relapsed disease or diagnosis of MDS and ≥ 5% BM blasts
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Absolute lymphocyte count (ALC) > 100/mm3
ALT and AST < 3.0 × the ULN
Participants with acute promyelocytic leukemia
Presence of active and clinically relevant central nervous system (CNS) disorder
Autoimmune disease requiring immunosuppressive treatment
Participants with known hepatic bridging cirrhosis
Single group
ARD103
Biological/VaccineARD103 autologous CAR-T cell therapy targeting CLL-1, single iv. infusion
Cyclophosphamide
Drugiv administration for lymphodepletion
Fludarabine
Drugiv administration for lymphodepletion
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The records of AEs and severity following the first infusion of ARD103.
To determine the RP2D of ARD103
RP2D of ARD103 following a 3+3 dose escalation schema (Phase 1)
To evaluate overall response rate (ORR)
The ORR will be evaluated by European Leukemia Net (ELN) criteria
Overall Survival (OS)
OS is defined as the time from ARD103 infusion to the date of death from any cause.
Progression-free survival (PFS)
PFS is defined as the time from the infusion of ARD103 infusion to the first recorded response of disease progression, relapse, or death due to any cause, whichever occurs first.
Time to best response
Time to best response is defined as the time from the infusion of ARD103 to the BOR.
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