The company voluntarily paused the trial in February 2022 to investigate 2 reported deaths in the trial.
Celyad Oncology's phase 1b clinical trial, KEYNOTE-B79 (NCT04991948) in refractory metastatic colorectal cancer (mCRC) is back on track after the FDA lifted its clinical hold which was placed back in March 2022.1
The hold, which was related to 2 deaths in the trial that involved similar pulmonary findings,2 was lifted following adjustments made to the trial's eligibility criteria.
The trial is evaluating Celyad's CYAD-101, a TCR inhibitory molecule (TIM)-based allogeneic NKG2D CAR T-cell therapy given concurrently with FOLFOX chemotherapy and followed by the anti-PD-1 therapy pembrolizumab (Keytruda; Merck) in adults with MCC with confirmed non-microsatellite instability high (non-MSI-H)/mismatch-repair proficient (pMMR) tumor status and recurrent or progressive diseases following at least 1 line of systemic therapy that must include FOLFOX chemotherapy.
With a target enrollment of 34 participants, study investigators are seeking to establish the ocurrence of dose-limiting toxicities that occur up to 73 days post-first study treatment administration, as well as the objective response rate at day 94, 6 weeks after the first pembrolizumab treatment administration.
CYAD-101 was previously evaluated in patients with mCRC in the phase 1 alloSHRINK clinical trial (NCT03692429), in which the agent demonstrated anti-tumor activity via partial responses in 2 out of 15 patients and stable disease in 9 patients. The median progression-free survival observed with CYAD-101 was 3.9 months and the treatment appeared to be safe and tolerable.
“We are pleased that the FDA lifted the clinical hold on this trial. We remain confident in the potential development of not only the candidate itself, but the continued development with our proprietary TIM technology," said Charles Morris, MD, chief medical officer of Celyad Oncology, in a statement. "CYAD-101 is currently our only clinical candidate co-expressing NKG2D and TIM, and we hope to continue to showcase our expertise with our non-gene edited technologies and explore additional opportunities to utilize NKG2D in allogeneic CAR T."