SHRINK study to evaluate the synergetic effect of the concurrent administration of CYAD-01 (CAR-T NKG2D) with standard chemotherapy in patients suffering from metastatic colorectal cancer.
SHRINK (Standard CHemotherapy Regimen and Immunotherapy with NKR-2) is an open-label Phase I study evaluating the safety and clinical activity of multiple doses of CYAD-01, administered concurrently with the neoadjuvant FOLFOX treatment in patients with potentially resectable liver metastases from colorectal cancer.
Dr. Christian Homsy, CEO of Celyad commented: “We are happy to start the SHRINK trial as it will allow us to evaluate the efficiency of our promising CYAD-01 therapy in combination with chemotherapy. We are confident that our partnership with key Belgian cancer institutions will provide us with new insights in the treatment of metastatic colorectal cancer. Today’s announcement, in conjunction with our ongoing THINK trial and the upcoming LINK study, reaffirms our commitment and dedication to beat cancer with a strong focus on solid tumors.”
Dr. Frédéric Lehmann, VP Clinical Development and Medical Affairs at Celyad added: “As leaders in our field, it is our task to further develop the potential of our CAR-T treatments. Starting SHRINK is another important milestone for us and for patients worldwide, evaluating the synergetic effect of the concurrent administration of our lead candidate CYAD-01 with standard chemotherapy as first-line treatment for metastatic colorectal cancers. We now look forward to the first infusion of a colorectal patient in the coming weeks and to the registration of other patients. The SHRINK study is one of the new Celyad studies to be initiated in 2017 as part of a global comprehensive clinical program supporting the development of our CYAD-01 candidate.”
SHRINK will be conducted in Belgium in key oncology centers. It contains a dose escalation and an extension stage. The dose escalation design will include three dose levels adjusted to body weight: up to 3x108, 1x109 and 3x109 of CYAD-01. At each dose, the patients will receive three successive administrations, two weeks apart at the specified dose. The dose escalation part of the study will enroll up to 18 patients while the extension phase would enroll 21 additional patients.
The colorectal cancer indication evaluated in the SHRINK trial was selected based on evidence generated in the pre-clinical settings and in the ongoing THINK study.
SHRINK is Celyad’s third clinical trial of its CYAD-01 product candidate, a CAR-T cell therapy using NKG2D ligands as a target. The two other trials are CM-CS1 (completed) and THINK (ongoing).