Celyad, a Belgium-based clinical-stage biopharmaceutical, announced Tuesday the early clinical results of a patient being treated of an aggressive type of leukemia that did not respond to chemotherapy with an alternative CAR-T cell therapy.
Christian Homsy, CEO of Celyad, said the patient with relapsed acute myeloid leukemia (AML) achieved Morphological Leukemia-Free Status (MLFS) with gene-engineered T-cells without pre-conditioning lymphodepletion or additional other concurrent treatment.
Homsy said they will now use the collected data to move forward to the next stage of the product development, reinforcing responses in as many clinical settings as possible.
The THINK trial (Therapeutic Immunotherapy with CAR-T NKG2D), conducted in the U.S. and Europe and used by Celyad, includes two stages: a dose escalation and an extension stage. The dose escalation is being conducted in parallel in solid cancers (colorectal, pancreatic, ovarian, triple negative breast and bladder) and in hematologic (AML and multiple myeloma) cancer groups, while the extension phase will evaluate in parallel each tumor type independently.
The dose escalation design includes three dose levels adjusted to body weight. At each dose, the patients receive three successive administrations, two weeks apart, of CYAD-01 at the specified dose.
To date, 14 patients have been dosed in the THINK trial. One Grade Three (severe toxicity) and one Grade Four (life-threatening toxicity) event have been observed, but both have resolved within 72 hours. No dose limiting toxicities (DLT) nor deaths related to the investigational product have been reported.
AML is a type of leukemia characterized by a rapid increase of abnormal white blood cells in the bone marrow, which in turn affects the production of normal blood cells. Over 20,000 people in the U.S. and almost as many people in Europe are diagnosed every year with AML.