ARCE Therapeutics, Inc.
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.
The investigational product (IP) for this study is ARD103, a C-type lectin-like molecule-1 (CLL-1) autologous chimeric antigen receptor T-cells (CAR-T). CLL-1 is highly expressed on both myeloid blasts and leukemia stem cells (LSCs) but is absent on normal hematopoietic stem cells (HSCs), suggesting CLL-1 as an excellent therapeutic target for AML and hence other potential myeloid malignancies.
Inclusion Criteria: * 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 * Adequate hematologic status: * Absolute lymphocyte count (ALC) \> 100/mm3 * Adequate renal, hepatic, cardiac and pulmonary function: * ALT and AST \< 3.0 × the ULN * Creatinine clearance ≥ 45.0 mL/min as estimated by Cockcroft-Gault and independent dialysis * Total bilirubin ≤ 2.0 mg/dL * Pregnancy testing: females of childbearing potential must have a negative serum or urine pre…
ARD103 autologous CAR-T cell therapy targeting CLL-1, single iv. infusion
iv administration for lymphodepletion
iv administration for lymphodepletion
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