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

Part of paid clinical trials in Duarte, California.

Sponsor
Cullinan Therapeutics Inc.
Study ID
NCT07722767
Phase
PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • AML (Acute Myeloid Leukemia)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CLN-049 — DRUG
    CLN-049 will be initiated using two step-up doses (SUDs), followed by the first target dose (TD) one week later, and weekly thereafter.
  • Azacitidine — DRUG
    Azacitidine 75 mg/m2 will initially be administered sub-cutaneous or intravenous on days 1 through 7 of a 28-day cycle
  • Venetoclax — DRUG
    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 Details

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 Dates

First listed
Jul 23, 2026
Start date
Oct 15, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2027
Completion
Aug 31, 2030

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Dose Escalation
    Newly diagnosed AML patients treated with standard of care azacitidine and venetoclax in addition to CLN-049 in dose escalation cohorts
  • Experimental: 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)

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 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Anthony Stein, MD (PRINCIPAL_INVESTIGATOR)
New York University Langone HealthNew YorkNew York10016
Mohammad Maher Abdul Hay, MD (PRINCIPAL_INVESTIGATOR)
MD AndersonHoustonTexas77030
Wei Ying Jen, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CANew York University Langone Health· New York, NYMD Anderson· Houston, TX

Related Studies