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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.

Study design
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.
What's involved
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.
Compensation
Not stated in the trial record.
Follow-up
The study will measure safety and determine the recommended dose over 48 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07722767

A Phase 1b Study of CLN-049 in Combination With Azacitidine and Venetoclax in AML Patients

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
Cullinan Therapeutics Inc.
~90 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:CLN-049AzacitidineVenetoclax

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over 48 weeks
+1 more outcome measured

Conditions

AML (Acute Myeloid Leukemia)

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Where it's being run

3 sites across 3 states
California1
New York1
Texas1

Who to contact

Timna Serino
[email protected]
617-410-4650
Email the study team

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What this trial measures

  • 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 venetoclax48 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 venetoclax48 weeks