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A Phase 1/2, Multicenter, First-in-Human, Dose Escalation and Expansion Study Evaluating CHM-029 as Monotherapy in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) With NPM1 Mutations, KMT2A or NUP98 Rearrangements

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The goal of this study is to evaluate the safety of CHM-029, an investigational oral medicine, and to evaluate its activity in treating certain types of acute myeloid leukemia (AML) in adults. The main questions the study aims to answer are: * What is an appropriate dose of CHM-029? * What side effects may occur with CHM-029? * How does the body process CHM-029? Researchers will evaluate increasing dose levels of CHM-029 to better understand its safety and how the body responds to treatment. Participants will visit the study clinic regularly for safety assessments, blood tests, electrocardiograms (ECGs), and bone marrow evaluations to monitor their health and response to treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years old and above

• Relapsed or refractory (R/R) acute myeloid leukemia (AML) and has had treatment with any available standard therapies

• Positive for NPM1 mutation, or KMT2A or NUP98 rearrangements

Locations
United States
Michigan
START Midwest
RECRUITING
Grand Rapids
Contact Information
Primary
Charm Study Contact
clinicaltrials@charmtx.com
312-682-0586
Time Frame
Start Date: 2026-08
Estimated Completion Date: 2029-03
Participants
Target number of participants: 40
Treatments
Experimental: CHM-029 Dose Escalation
Participants will receive CHM-029 orally. Dose levels will be escalated based on dose limiting toxicities (DLTs) as evaluated by the Safety Review Committee (SRC).
Experimental: CHM-029 Backfill
Participants will receive CHM-029 orally at a dose level already evaluated by the Safety Review Committee (SRC).
Related Therapeutic Areas
Sponsors
Leads: Charm Therapeutics

This content was sourced from clinicaltrials.gov