A Phase 1b Study of CLN-049 in Combination With Azacitidine and Venetoclax in AML Patients
Starting soon · Phase 1
Conditions studied: AML (Acute Myeloid Leukemia)
In brief
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.
Key facts
- Study ID
- NCT07722767
- Run by
- Cullinan Therapeutics Inc.
- People needed
- 90
- Starts
- 2026-10-15
- Expected to finish
- 2030-08-31
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 2
- The patient's laboratory values meet the following criteria:
- Creatinine clearance (CrCl) ≥ 45 mL/min;
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN
You may not qualify if…
- 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.
- Active CNS involvement by AML.
- Signs of leukostasis requiring urgent therapy.
- Prior organ allograft, or prior allogeneic hematopoietic stem cell transplant within the last 12 months, or with active graph-versus-host disease.
- Treatment with systemic glucocorticoid therapy or other immune-suppressive drugs ≤ 14 days prior to the first dose of CLN-049.
- Patients with concomitant second malignancies requiring active treatment in the past 12 months, or if additional therapy is required or anticipated during study participation.
- 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
- Active uncontrolled infection until infection is treated and brought under control.
- Has a history of, or a positive test for human immunodeficiency virus (HIV) 1/2 or primary immunodeficiency disease such as HIV.
- Known history of hepatitis B, hepatitis C (HCV) infection, or acute hepatitis A.
- Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
- 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
- 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.
- 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.
- QT interval corrected for heart rate using Fridericia's formula (QTcF) of ≥ 480 milliseconds.
- 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.
- Known history of prior human anti-human antibody response.
Where it is running
- City of Hope — Duarte, California, United States
- New York University Langone Health — New York, New York, United States
- MD Anderson — Houston, Texas, United States
Full record on ClinicalTrials.gov
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