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.
Sequential
CLN-049
DrugCLN-049 will be initiated using two step-up doses (SUDs), followed by the first target dose (TD) one week later, and weekly thereafter.
Azacitidine
DrugAzacitidine 75 mg/m2 will initially be administered sub-cutaneous or intravenous on days 1 through 7 of a 28-day cycle
Venetoclax
DrugVenetoclax will initially be administered orally on days 1 through 28 of a 28-day cycle and then reduced to days 1 through 14 in consolidation cycles.
Incidence and severity of adverse events (AEs)/adverse events of special interest (AESIs)/serious adverse events (SAEs) [safety and tolerability] of CLN-049 combined with azacitidine and venetoclax
Safety assessments include: body measurements, vital signs, physical exam, EGOG (measure of patient function in terms of self-care, daily activity, and physical ability) performance status, lab assessments, ECGs, and ECHO/MUGA (tests to evaluate heart function)
Determine recommended dose/schedule of CLN-049 in combination with azacitidine and venetoclax
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