Cardio3 BioSciences Announces Infusion of First Patient in NKG2D Phase I Trial with no short term adverse events.
- No short term on-target, off-tumor toxicity observed to date in first patient following single dose NKG2D CAR T-cell infusion; marks an important step in therapy evaluation.
- Staggered enrolment of 2 additional patients to be expected after a 30 day follow-up observation of the initial patient.
- The trial is a dose escalation study evaluating safety and feasibility of a CAR T-cell therapy in patients with acute myeloid leukemia or multiple myeloma.
Mont-Saint-Guibert, Belgium – Cardio3 BioSciences (Euronext Brussels and Paris: CARD), soon to be renamed Celyad, a leader in engineered cell-therapy treatments today announced the infusion of the first patient enrolled in the Company’s Phase I clinical trial evaluating the safety and feasibility of its NKG2D CAR T-cell therapy, in cancer patients suffering from acute myeloid leukemia (AML) or multiple myeloma (MM).
This Phase I trial is a dose escalating study. Following the infusion of the first dose of NKG2D CAR Tcell, there were no short term adverse events observed in that patient. A pre-defined, staggered enrolment of two additional patients at the same dose level is expected to occur after an additional 30-day safety assessment of the first infused patient.
Dr. Christian Homsy, CEO of Cardio3 BioSciences, commented: “The infusion of the first patient enrolled in our initial Phase I trial evaluating NKG2D CAR T-cell marks a significant milestone in developing our immuno-oncology program. Once the preliminary 30 days safety evaluation will have been completed, we expect to continue enrolment in the study to further evaluate the therapy’s safety and hopefully efficacy. We believe NKG2D CAR T-cell could emerge as a new and viable treatment option for patients with a broad range of cancer types, with potential application in patients with haematological malignancies and beyond.”
Dr. Vincent Brichard, Vice President Immuno-oncology of Cardio3 BioSciences, added: “The absence of short term adverse events of NKG2D CAR T-cell observed in the first days following infusion of the first patient is an important step in the initial evaluation of the safety profile of the therapy. According to the trial design, this first patient will be monitored closely over the next 30 days before we expand enrolment to two additional patients at the same dose level, followed by the next dose level with a second cohort of patients. This dose-escalation trial is expected to enrol a total of approximately 24 patients and we look forward to providing updates as the trial advances.”
The Phase I trial, anticipated to be completed in mid-2016, is assessing the safety and feasibility of NKG2D CAR T-cell as primary endpoints, with secondary endpoints including clinical efficacy.
NKG2D CAR T-cell is an autologous chimeric antigen receptor T lymphocyte (CAR T-cell) therapy constructed using the native sequence of natural killer cell (NK cell) receptors which, unlike traditional CAR technologies such as those targeting the CD19 antigen, has the potential to target a broad range of solid tumors and blood cancers by targeting ligands present on numerous cancer types. The research underlying this technology was originally conducted at Dartmouth College by Professor Charles Sentman, and has been published in numerous peer-reviewed publications such as Journal of Immunology, Cancer Research and Blood.
