[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07722767":3,"trial-entities:NCT07722767":107,"trial-summary:NCT07722767":112},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":46,"secondary_outcomes":53,"sex":54,"minimum_age":55,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":56,"std_ages":60,"locations":63,"central_contacts":98,"overall_officials":104,"references":105,"see_also_links":106},"NCT07722767","CLN-049-AML-103","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","NOT_YET_RECRUITING","2030-08-31","2026-07","2026-07-23","2026-10-15","Cullinan Therapeutics Inc.","INDUSTRY",false,"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.",null,[19],"AML (Acute Myeloid Leukemia)",[21,22],"Newly diagnosed AML","TP53-mutated AML","INTERVENTIONAL","TREATMENT",[26],"PHASE1",{"count":28,"type":29},90,"ESTIMATED",[31,38,42],{"type":32,"name":33,"description":34,"armGroupLabels":35},"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.",[36,37],"Part A: Dose Escalation","Part B: Dose Expansion",{"type":32,"name":39,"description":40,"armGroupLabels":41},"Azacitidine","Azacitidine 75 mg\u002Fm2 will initially be administered sub-cutaneous or intravenous on days 1 through 7 of a 28-day cycle",[36,37],{"type":32,"name":43,"description":44,"armGroupLabels":45},"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.",[36,37],[47,51],{"measure":48,"description":49,"timeFrame":50},"Incidence and severity of adverse events (AEs)\u002Fadverse events of special interest (AESIs)\u002Fserious 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\u002FMUGA (tests to evaluate heart function)","48 weeks",{"measure":52,"timeFrame":50},"Determine recommended dose\u002Fschedule of CLN-049 in combination with azacitidine and venetoclax",[],"ALL","18 Years",{"inclusion":57,"exclusion":58,"raw_text":59},[],[],"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.",[61,62],"ADULT","OLDER_ADULT",[64,77,87],{"facility":65,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":74},"City of Hope","Duarte","California","91010","United States",[71],{"name":72,"role":73},"Anthony Stein, MD","PRINCIPAL_INVESTIGATOR",{"lat":75,"lon":76},34.13945,-117.97729,{"facility":78,"city":79,"state":79,"zip":80,"country":69,"contacts":81,"geoPoint":84},"New York University Langone Health","New York","10016",[82],{"name":83,"role":73},"Mohammad Maher Abdul Hay, MD",{"lat":85,"lon":86},40.71427,-74.00597,{"facility":88,"city":89,"state":90,"zip":91,"country":69,"contacts":92,"geoPoint":95},"MD Anderson","Houston","Texas","77030",[93],{"name":94,"role":73},"Wei Ying Jen, MD",{"lat":96,"lon":97},29.76328,-95.36327,[99],{"name":100,"role":101,"phone":102,"email":103},"Timna Serino","CONTACT","617-410-4650","ClinOps@cullinantx.com",[],[],[],{"nct_id":4,"conditions":108,"biomarkers":110},[109],"Acute Myeloid Leukemia",[111],"TP53 Gene",{"nct_id":4,"found":113,"summary":114,"prompt_version":124},true,{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is a Phase 1b, open-label study, meaning both you and your doctors will know which treatments you are receiving. It will involve about 90 participants.","completed","Phase 1b Study of CLN-049 for Newly Diagnosed AML","This study is testing a new drug called CLN-049 in combination with two existing drugs, azacitidine and venetoclax, for people with newly diagnosed acute myeloid leukemia (AML). AML is a type of blood cancer. The main goals are to see how safe this combination is and to find the best dose of CLN-049 when given with azacitidine and venetoclax. You might be able to join if you are at least 18 years old, have newly diagnosed AML, and cannot have standard intensive chemotherapy. The study plans to enroll about 90 participants. The study is looking at how the drugs affect a pathway called RAF.","The study will measure safety and determine the recommended dose over 48 weeks.",104,"CLN-049 will be given weekly after initial step-up doses. Azacitidine is given on days 1-7 of a 28-day cycle, and venetoclax is given on days 1-28, then days 1-14 in later cycles.","Not stated in the trial record.",[33,39,43],"v2"]