AML (Acute Myeloid Leukemia)Phase 1NCT07722767
A Phase 1b Study of CLN-049 in Combination With Azacitidine and Venetoclax in AML Patients
A Phase 1 study testing CLN-049, Azacitidine and Venetoclax in people with AML (Acute Myeloid Leukemia), run by Cullinan Therapeutics Inc. at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML (Acute Myeloid Leukemia)
- What is being tested?
- CLN-049, Azacitidine and Venetoclax
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Oct 2026to 31 Aug 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 18 years of age with newly diagnosed, previously untreated AML (including MDS/AML)
- De novo and secondary AML are eligible
- Patients with molecularly defined AML subtypes (including but not limited to FLT3-mutated, IDH1/2-mutated, NPM1-mutated, KMT2A rearranged, and TP53-mutated AML) are eligible
- Patients with TP53-mutated AML are eligible
- White blood cell (WBC) count at the time of C1D1 ≤ 20,000/μL
- Patients must have previously untreated AML; No prior AML treatment other than hydroxyurea for cytoreduction and one dose of intrathecal chemotherapy for suspected central nervous system (CNS) involvement (that is ruled out) is allowed. Prior therapy for MDS is allowed except for hypomethylating agents and venetoclax.
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- 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
Who cannot join
- Patients willing and able to receive standard intensive chemotherapy.
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
Emory University Hospital
Atlanta, Georgia, 30322
Colin Vale, MD
City of Hope
Duarte, California, 91010
Anthony Stein, MD
MD Anderson
Houston, Texas, 77030
Wei Ying Jen, MD
University of Miami Health System
Miami, Florida, 33136
Namrata Chandhok, MD
New York University Langone Health
New York, New York, 10016
Mohammad Maher Abdul Hay, MD
About this study
Official title: 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
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.
- Conditions
- AML (Acute Myeloid Leukemia)
- Being tested
- CLN-049, Azacitidine, Venetoclax
- Keywords
- Newly diagnosed AML, TP53-mutated AML
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLN-049Drug
CLN-049 will be initiated using two step-up doses (SUDs), followed by the first target dose (TD) one week later, and weekly thereafter.
AzacitidineDrug
Azacitidine 75 mg/m2 will initially be administered sub-cutaneous or intravenous on days 1 through 7 of a 28-day cycle
VenetoclaxDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: CLN-049; Drug: Azacitidine; Drug: Venetoclax |
| Part B: Dose Expansion | Experimental | 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) Receives: Drug: CLN-049; Drug: Azacitidine; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 48 weeks
Determine recommended dose/schedule of CLN-049 in combination with azacitidine and venetoclax
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start15 Oct 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML (Acute Myeloid Leukemia)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cullinan Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722767
- Sponsor's protocol ID
- CLN-049-AML-103
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07722767
- Acronym / sponsor ID
- CLN-049-AML-103
- Conditions
- AML (Acute Myeloid Leukemia)
- Keywords
- Newly diagnosed AML, TP53-mutated AML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cullinan Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Dose Escalation | Experimental | Drug: CLN-049, Drug: Azacitidine, Drug: VenetoclaxNewly diagnosed AML patients treated with standard of care azacitidine and venetoclax in addition to CLN-049 in dose escalation cohorts |
| Part B: Dose Expansion | Experimental | Drug: CLN-049, Drug: Azacitidine, Drug: VenetoclaxNewly 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients aged ≥ 18 years of age with newly diagnosed, previously untreated AML (including MDS/AML)
- White blood cell (WBC) count at the time of C1D1 ≤ 20,000/μL
- Patients must have previously untreated AML; No prior AML treatment other than hydroxyurea for cytoreduction and one dose of intrathecal chemotherapy for suspected central nervous system (CNS) involvement (that is ruled out) is allowed. 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:
Key exclusion criteria (21 listed)
- Patients willing and able to receive standard intensive chemotherapy.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLN-049CLN-049 will be initiated using two step-up doses (SUDs), followed by the first target dose (TD) one week later, and weekly thereafter. | Drug | Part A: Dose Escalation, Part B: Dose Expansion |
| AzacitidineAzacitidine 75 mg/m2 will initially be administered sub-cutaneous or intravenous on days 1 through 7 of a 28-day cycle | Drug | Part A: Dose Escalation, Part B: Dose Expansion |
| VenetoclaxVenetoclax 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. | Drug | Part A: Dose Escalation, Part B: Dose Expansion |
Primary outcome
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
Time frame: 48 weeks
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
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CLN-049, Azacitidine and Venetoclax in people with AML (Acute Myeloid Leukemia), run by Cullinan Therapeutics Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timna Serino (617-410-4650, ClinOps@cullinantx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.