On September 5, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported the successful injection of the first patient under the amended protocol of the THINK trial, which assesses treatment with CYAD-01 after a non-myeloablative preconditioning chemotherapy regimen of cyclophosphamide and fludarabine in refractory metastatic colorectal cancer (CRC) patients (Press release, Celyad, SEPT 5, 2018, View Source [SID1234529285]).
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"The first dosing of CYAD-01 in the amended THINK trial marks another important step for our company," said Dr. Christian Homsy, CEO of Celyad. "CYAD-01 has shown promising signs of clinical activity as a standalone approach, and we are committed to maximizing the clinical benefit for patients by evaluating CYAD-01 in a range of clinical settings. We aim to evaluate the anti-tumor activity of CYAD-01 not only as a standalone approach, but also with prior preconditioning and standard of care chemotherapy in both hematological malignancies and solid tumors. These additional studies will elucidate the best clinical path forward for a patient population severely in need of new therapeutic options."
The amended THINK is a single arm, open-label, Phase I study designed to evaluate the safety and anti-tumor activity of CYAD-01 only in metastatic CRC patients following the administration of cyclophosphamide (300 mg/m²) and fludarabine (30 mg/m²). Based on initial data from the trial, a per protocol expansion cohort may be initiated.
CYAD-01 is an investigational CAR-T therapy in which a patient’s T cells are engineered to express the chimeric antigen receptor NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells. CYAD-01 is currently in clinical development through a number of trials for hematological malignancies and solid tumors.