A Phase 1b, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenously (IV) administered CLN-049 in combination with azacitidine (Aza) and venetoclax (Ven) in patients with newly diagnosed (ND) AML.
Patients aged ≥ 18 years of age with newly diagnosed, previously untreated AML (including MDS/AML)
Patients are not candidates for intensive induction chemotherapy because they are either unfit or otherwise clinically unsuitable for anthracycline/ cytarabine-based induction therapy
White blood cell (WBC) count at the time of C1D1 ≤ 20,000/μL
Patients must have previously untreated AML; hydroxyurea for cytoreduction is permitted up to C1D1. Prior therapy for MDS is allowed except for hypomethylating agents and venetoclax.
Isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement with AML to enter the study).
Diagnosis of acute promyelocytic leukemia or PML:RARA-positive AML.
Chronic myeloid leukemia in blast phase or AML with BCR:ABL1.
Mixed phenotype acute leukemia or acute leukemia of ambiguous lineage.