Celyad has dosed the first patients in its SHRINK and LINK trials, injecting subjects with CYAD-01, an NKG2D receptor.
SHRINK is an open-label Phase I trial designed to investigate the safety and clinical activity of multiple doses of CYAD-01 as a treatment for patients with resectable liver metastases from colorectal cancer.
As part of the trial, CYAD-01 will be administered concurrently with the neoadjuvant FOLFOX treatment to the enrolled patients.
The trial’s dose escalation phase includes three dose levels of CYAD-01. At each dose, the patients will be given three successive administrations two weeks apart at the specified dose.
So far, the trial has not reported any adverse events.
LINK is an open-label Phase I trial that seeks to analyse the safety and clinical activity of multiple doses of CYAD-01.
The trial will follow a loco-regional approach while treating patients with CYAD-01 administration by providing a number of hepatic transarterial injections to colorectal cancer patients diagnosed with unresectable liver metastases.
Its dose escalation phase will feature three dose levels of CYAD-01 and will be similar to that of the SHRINK trial.
Celyad CEO Dr Christian Homsy said: “CYAD-01, concurrently administered with standard chemotherapy FOLFOX in SHRINK, or administered through hepatic transarterial injections in LINK appears to have been well–tolerated to date.
“We are particularly satisfied with the lack of on-target/off-tumour toxicity observed to date in the context of the combination of CYAD-01 with chemotherapy.”
Celyad expects to begin the EPITHINK trial of CYAD-01 for the treatment of Acute Myeloid Leukemia (AML) soon.
The company also plans to initiate DEPLETHINK AML and DEPLETHINK CRC trials of CYAD-01 for AML over the next few weeks.