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

NCT07722767 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-07-23

No results posted yet for this study

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.

Conditions

  • AML (Acute Myeloid Leukemia)

Interventions

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.

DRUG

Azacitidine

Azacitidine 75 mg/m2 will initially be administered sub-cutaneous or intravenous on days 1 through 7 of a 28-day cycle

DRUG

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.

Sponsors & Collaborators

  • Cullinan Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-15
Primary Completion
2027-09-30
Completion
2030-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07722767 on ClinicalTrials.gov