Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06285890

Phase I Study of HC-7366 for Acute Myeloid Leukemia

Led by M.D. Anderson Cancer Center · Updated on 2026-05-05

18

Participants Needed

1

Research Sites

293 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

H

HiberCell, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

To find a recommended dose of HC-7366 to patients with AML. The safety and effects of this drug combination will also be studied.

CONDITIONS

Official Title

Phase I Study of HC-7366 for Acute Myeloid Leukemia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of AML or MDS/AML with 10% to 19% blasts as per classifications
  • Age 18 years or older with relapsed/refractory AML or MDS/AML without standard treatment options
  • Relapsed or refractory disease defined by specific bone marrow and blood blast criteria
  • Prior appropriate therapy including intensive induction chemotherapy or venetoclax regimens
  • ECOG performance status 0 to 2
  • Patients relapsing after allogeneic stem cell transplant who have recovered and are off immunosuppression with limited chronic GVHD
  • Patients with actionable mutations exhausted FDA-approved treatments
  • Adequate liver function with specified bilirubin and liver enzyme limits
  • Adequate kidney function with creatinine clearance of at least 45 mL/min
  • Agreement to use contraception during and after the study as detailed
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Presence of t(15;17) chromosomal abnormality
  • White blood cell count above 15 x 10^9/L despite allowed supportive treatments
  • Use of cytotoxic chemotherapy, targeted therapy, radiation, immunotherapy, or clinical trial treatments within 2 weeks before study drug
  • Known symptomatic or uncontrolled central nervous system leukemia
  • Active systemic infections not improving with treatment
  • Severe gastrointestinal or metabolic conditions affecting oral drug absorption
  • Uncontrolled serious heart or lung conditions
  • Active hepatitis B or C infection with detectable virus or known HIV infection
  • Certain heart rhythm abnormalities or prolonged QT interval unless corrected
  • Previous malignancies unless definitively treated and stable as specified
  • Major surgery or unhealed major wounds within 4 weeks before screening
  • Legal protection status or uncontrolled psychiatric conditions or substance abuse interfering with participation
  • Known allergy to study drug components
  • Nursing women or women of childbearing potential with positive pregnancy test or unwillingness to use contraception
  • Pregnant or breastfeeding women
  • First-degree relatives of study investigators, staff, or sponsor

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

A

Abhishek Maiti, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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