Celyad presents preliminary interim data from SHRINK, alloSHRINK trials
Celyad announced that Professor Dr. Eric Van Cutsem from the University Hospital of Leuven presented preliminary interim data from the ongoing SHRINK and alloSHRINK Phase 1 trials assessing safety and clinical activity of the NKG2D-based CAR-T therapies CYAD-01 and CYAD-101 for the treatment of metastatic colorectal cancer at the European Society for Medical Oncology 21st World Congress on Gastrointestinal Cancer. Following the oral and poster presentations at WCGIC, Celyad's management team will host a conference call to discuss the initial clinical results from the SHRINK and alloSHRINK trials. To date, nine mCRC patients have been enrolled as part of the dose-escalation, SHRINK Phase 1 trial evaluating CYAD-01 administered concurrently with FOLFOX chemotherapy. Patient enrollment included four neoadjuvant first-line treatment CRC patients with resectable liver metastasis and five non-resectable mCRC patients with prior multiple chemotherapy lines including FOLFOX and/or FOLFIRI chemotherapy. The mean number of prior therapies received for the relapsed/refractory mCRC patients enrolled was three. Treatment with CYAD-01 with standard FOLFOX chemotherapy was generally well-tolerated, with no reports of cytokine release syndrome grade 2 or higher, related serious adverse events, dose-limiting toxicities, nor on-target off-tumor toxicity, according to Celyad. Preliminary data show a dose-dependent effect on the kinetics of cells with higher levels of cell engraftment at higher doses of CYAD-01 doses, it added. Of the nine mCRC patients, one neoadjuvant patient experienced a partial response according to RECIST 1.1 criteria and a total of six patients experienced stable disease at month three, including two neoadjuvant and four relapsed/refractory mCRC patients. To date, a total of six patients with relapsed/refractory mCRC have been enrolled in the two first dose-level in the alloSHRINK Phase 1 trial. No clinical evidence of graft-versus-host disease have been observed. Further, "Encouraging anti-tumor activity was observed in one patient experiencing a partial response (PR) and three patients experiencing stable disease at month 3," added Celyad.