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NCT07751991RecruitingPhase 1

A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML

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

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
40 (estimated)
First submitted
30 Jul 2026
Start date
28 Sept 2026
Primary completion date
Dec 2027
Lead sponsor
Charm Therapeutics
NCT number
NCT07751991
EU CT number
2026-526409-14-00
EudraCT number
2026-526409-14

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 40
  • From 28 Sept 2026 to the primary completion date, Dec 2027
  • 18 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has current complications related to hematopoietic stem cell transplant (HSCT)
  • Central nervous system involvement refractory to intrathecal chemotherapy and/or standard cranial-spinal radiation

Other illness

  • Other cancers that require treatment
  • Active Hepatitis or HIV infection
  • Moderate hepatic or renal impairment
  • Congestive heart failure NYHA Class 3 or 4

Lab values

  • White blood cell (WBC) count higher than 25,000 u/L that cannot be maintained below threshold with hydroxyurea treatment
  • Baseline prolongation of QT/QTc interval (≥ 470 ms) or additional risk factors for Torsades de Pointes (TdP)

Other

  • Extramedullary only AML
  • Acute promyelocytic leukemia

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Charite Universitaetsmedizin Berlin KöR
Coordinator of this site? Confirm its status
BerlinGermanyNot yet recruiting
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Coordinator of this site? Confirm its status
MunichGermanyNot yet recruiting
Hospital San Pedro De Alcántara
Coordinator of this site? Confirm its status
CáceresSpainNot yet recruiting
Hospital Universitario Fundación Jiménez Díaz
Coordinator of this site? Confirm its status
MadridSpainNot yet recruiting
Clínica Universidad de navarra
Coordinator of this site? Confirm its status
PamplonaSpainNot yet recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainNot yet recruiting
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceNot yet recruiting
Oncopole Claudius Regaud
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Toulouse Cedex 9FranceNot yet recruiting
The Christie NHS Foundation Trust
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ManchesterUnited KingdomRecruiting
Oxford University Hospitals NHS Foundation Trust
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OxfordUnited KingdomRecruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsNot yet recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Coordinator of this site? Confirm its status
RotterdamNetherlandsNot yet recruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandNot yet recruiting
MTZ Clinical Research powered by Pratia
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WarsawPolandNot yet recruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Coordinator of this site? Confirm its status
WroclawPolandNot yet recruiting
City of Hope Center Medical Center
Coordinator of this site? Confirm its status
DuarteUnited StatesRecruiting
START | Midwest
Coordinator of this site? Confirm its status
Grand RapidsUnited StatesRecruiting
Yale - New Haven Hospital / Cancer Center
Coordinator of this site? Confirm its status
New HavenUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.