Hemogenyx Pharmaceuticals has announced encouraging progress in its Phase I clinical trial of HG-CT-1, a CAR-T cell therapy targeting relapsed/refractory acute myeloid leukemia (AML) in adults.
The company confirmed that the third patient enrolled in the study has now been successfully treated. The therapy was well tolerated, meeting the trial’s predefined initial safety criteria, and importantly, early signs of clinical efficacy have been observed.
A preliminary assessment indicated that the patient’s original AML cells were not detectable using standard testing methods.
Safety data from the first three patients—treated at the lowest dose level—will now be submitted to an independent Data Safety Monitoring Board (DSMB). The DSMB will review the findings and determine whether the trial can progress to dose escalation.
Beyond safety, the trial is designed to evaluate secondary endpoints, including efficacy assessments based on AML-specific response criteria and overall survival outcomes.
Hemogenyx said the results to date mark a significant milestone in advancing HG-CT-1 as a potential new treatment option for patients with limited therapeutic alternatives.
Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented:
“The successful treatment of the third patient marks another important milestone for Hemogenyx Pharmaceuticals and for patients battling relapsed or refractory AML. We are encouraged by the favorable safety profile observed to date, together with the early signals of efficacy. These results reinforce the promise of HG-CT-1 as a potential new therapy for one of the most aggressive and intractable forms of leukemia. We remain committed to advancing the clinical development of this therapy to address a critical unmet medical need, while also creating long-term value for our shareholders.“
