Phase I Study of HC-7366 for Acute Myeloid Leukemia
ConditionAcute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
To find a recommended dose of HC-7366 to patients with AML. The safety and effects of this drug combination will also be studied.
Eligibility criteria
Qualifiers
Patients need to have a confirmed diagnosis of AML, or MDS/AML with 10% to 19% blasts, per the International Consensus Classification 2022 or the WHO 2022 classification.
Patients ≥18 years with R/R AML or R/R MDS/AML, other than acute promyelocytic leukemia (APL), with no available standard treatment options.
ECOG PS 0 to 2
Patients relapsing after allo-SCT may be eligible if they have recovered from all transplantrelated toxicities and are off all immunosuppression, with no more than grade 1 chronic GVHD. Physiologic ("replacement") dose of steroids (≤10 mg prednisone or equivalent) may be acceptable. Patients must be off all immunosuppression, including calcineurin inhibitors, for at least 2 weeks or 5 half-lives, whichever is longer, prior to enrollment on study.
Disqualifiers
Patients with t(15;17) karyotypic abnormality.
Patient has a white blood cell count > 15 x 10⁹/L. Hydroxyurea, and/or cytarabine (up to 2 g/m2 total) used as supportive care is permitted to meet this criterion.
Prior use of any cytotoxic chemotherapy, targeted therapy, radiation therapy, immunotherapy, or other clinical trial therapies within 2 weeks, prior to first dose of study treatment. Patients should have recovered from all prior therapy related toxicities. Patients may receive hydroxyurea or cytarabine for control of WBC count during this washout period.
Patients with known symptomatic or uncontrolled CNS leukemia.
Trial design
Treatments tested in this trial
- HC-7366
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
HiberCell, Inc.
Collaborator
Source ClinicalTrials.gov