[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648481":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":35,"locations":41,"responsibleParty":84,"collaborators":26,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":26,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":26,"enrollmentInfo":95,"targetDuration":26,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":107,"whyStopped":26,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Cullinan Therapeutics Inc.","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: Dose Escalation","EXPERIMENTAL","Newly diagnosed AML patients treated with standard of care azacitidine and venetoclax in addition to CLN-049 in dose escalation cohorts",[13,14,15],"Drug: CLN-049","Drug: Azacitidine","Drug: Venetoclax",{"label":17,"type":10,"description":18,"interventionNames":19},"Part B: Dose Expansion","Newly diagnosed AML patients treated with standard of care azacitidine and venetoclax in addition to CLN-049 at a dose determined in Part A (Dose Escalation)",[13,14,15],[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","CLN-049","CLN-049 will be initiated using two step-up doses (SUDs), followed by the first target dose (TD) one week later, and weekly thereafter.",[9,17],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Azacitidine","Azacitidine 75 mg\u002Fm2 will initially be administered sub-cutaneous or intravenous on days 1 through 7 of a 28-day cycle",[9,17],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Venetoclax","Venetoclax 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.",[9,17],[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Timna Serino","CONTACT","617-410-4650","ClinOps@cullinantx.com",[42,59,71],{"facility":43,"status":26,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"City of Hope","Duarte","California","91010","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-117.97729,34.13945,{"lat":53,"lon":52},[56],{"name":57,"role":58,"phone":26,"phoneExt":26,"email":26},"Anthony Stein, MD","PRINCIPAL_INVESTIGATOR",{"facility":60,"status":26,"city":61,"state":61,"zip":62,"country":47,"countryCode":48,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"New York University Langone Health","New York","10016",{"type":50,"coordinates":64},[65,66],-74.00597,40.71427,{"lat":66,"lon":65},[69],{"name":70,"role":58,"phone":26,"phoneExt":26,"email":26},"Mohammad Maher Abdul Hay, MD",{"facility":72,"status":26,"city":73,"state":74,"zip":75,"country":47,"countryCode":48,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"MD Anderson","Houston","Texas","77030",{"type":50,"coordinates":77},[78,79],-95.36327,29.76328,{"lat":79,"lon":78},[82],{"name":83,"role":58,"phone":26,"phoneExt":26,"email":26},"Wei Ying Jen, MD",{"type":85,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100648481","phase-1-a-phase-1b-study-of-cln-049-in-combination-with-azacitidine-and-venetoclax-in-aml-patients-100648481",false,"NCT07722767","A Phase 1b Study of CLN-049 in Combination With Azacitidine and Venetoclax in AML Patients","A Phase 1b Dose Escalation and Dose Expansion Study of CLN 049 in Combination With Azacitidine and Venetoclax for the Treatment of Adult Patients With Newly Diagnosed, Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Patients aged ≥ 18 years of age with newly diagnosed, previously untreated AML (including MDS\u002FAML)\n2. Patients are not candidates for intensive induction chemotherapy because they are either unfit or otherwise clinically unsuitable for anthracycline\u002F cytarabine-based induction therapy\n3. White blood cell (WBC) count at the time of C1D1 ≤ 20,000\u002FμL\n4. 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.\n5. Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 2\n6. The patient's laboratory values meet the following criteria:\n\n   1. Creatinine clearance (CrCl) ≥ 45 mL\u002Fmin;\n   2. Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n   3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN\n\nExclusion Criteria:\n\n1. Isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement with AML to enter the study).\n2. Diagnosis of acute promyelocytic leukemia or PML:RARA-positive AML.\n3. Chronic myeloid leukemia in blast phase or AML with BCR:ABL1.\n4. Mixed phenotype acute leukemia or acute leukemia of ambiguous lineage.\n5. Active CNS involvement by AML.\n6. Signs of leukostasis requiring urgent therapy.\n7. Prior organ allograft, or prior allogeneic hematopoietic stem cell transplant within the last 12 months, or with active graph-versus-host disease.\n8. Treatment with systemic glucocorticoid therapy or other immune-suppressive drugs ≤ 14 days prior to the first dose of CLN-049.\n9. Patients with concomitant second malignancies requiring active treatment in the past 12 months, or if additional therapy is required or anticipated during study participation.\n10. Patients with any active autoimmune disease or a history of known or suspected autoimmune disease, or history of a syndrome that requires systemic corticosteroids or immunosuppressive medications\n11. Active uncontrolled infection until infection is treated and brought under control.\n12. Has a history of, or a positive test for human immunodeficiency virus (HIV) 1\u002F2 or primary immunodeficiency disease such as HIV.\n13. Known history of hepatitis B, hepatitis C (HCV) infection, or acute hepatitis A.\n14. Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.\n15. Patients who have received an investigational agent (for any indication) within 5 half-lives of the agent and until toxicity from this has resolved to Grade 1 or less\n16. History of the following events in conjunction with prior treatment with immunotherapy: Grade 3 or greater neurotoxicity, ocular toxicity, pneumonitis, myocarditis, or colitis; liver dysfunction meeting the laboratory criteria for Hy's Law.\n17. Live virus vaccines within 28 days of the first dose of CLN-049, during treatment, and until the end of last dose of CLN-049.\n18. QT interval corrected for heart rate using Fridericia's formula (QTcF) of ≥ 480 milliseconds.\n19. Patient has a history of drug-related anaphylactic reactions to any components of CLN-049, or a history of Grade 4 anaphylactic reaction to any bispecific molecule or monoclonal antibody therapy.\n20. Known history of prior human anti-human antibody response.","ALL","18 Years",{"count":96,"type":97},90,"ESTIMATED","INTERVENTIONAL",[100],"PHASE1","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.",[103],"AML (Acute Myeloid Leukemia)",[105,106],"Newly diagnosed AML","TP53-mutated AML","NOT_YET_RECRUITING","2026-07-19",{"date":110,"type":111},"2026-07-23","ACTUAL",{"date":113,"type":97},"2026-10-15",{"date":115,"type":97},"2030-08-31",{"name":5,"class":6},3]