Celyad Oncology Presents Data Update from Phase 1 alloSHRINK Trial for CYAD-101 in mCRC at ASCO-GI Symposium - Seite 2
- Recent analysis of the dose-escalation segment of the alloSHRINK trial showed median overall survival (mOS) was 10.6 months
- Tumor burden decrease was observed in eight of 15 patients, including six of nine patients at dose level 3 (1x109 cells per infusion)
- Of four patients treated at the highest dose level of 1x109 CYAD-101 cells per infusion available for analysis, three patients who achieved either a confirmed PR or SD also showed hyper-expanded TCR repertoire post-treatment through the emergence of new T cell clones in the peripheral blood T cell repertoire, while the patient with progressive disease displayed no evidence of new T cell clones
- Cytokine modulation was also observed after the first and second infusions of CYAD-101 in the patient who achieved a confirmed PR from the highest dose level
Next Steps
- Preliminary data from the expansion cohort of the Phase 1 alloSHRINK trial are expected during the first half of 2021
- Initiation of the Phase 1b KEYNOTE-B79 trial of CYAD-101 following FOLFIRI, with Merck’s KEYTRUDA in refractory mCRC patients with microsatellite stable (MSS) / mismatch-repair proficient (pMMR) disease is expected to be initiated during the first half of 2021
About CYAD-101 and alloSHRINK Trial
CYAD-101 is an investigational, non-gene edited, allogeneic (healthy donor derived) CAR T candidate engineered to co-express a chimeric antigen receptor based on NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands and the novel inhibitory peptide TIM. The expression of TIM reduces signaling of the TCR complex, which is responsible for graft-versus host disease.
Lesen Sie auch
alloSHRINK is an open-label Phase 1 trial assessing the safety and clinical activity of three consecutive administrations of CYAD-101 every two weeks administered concurrently with preconditioning chemotherapy in patients with refractory mCRC. The dose-escalation segment of the trial evaluated the administrations of CYAD-101 concurrently with FOLFOX (combination of 5-fluorouracil, leucovorin and oxaliplatin) chemotherapy regimen. In the expansion cohort of the trial, CYAD-101 will be administered at the recommended dose of one billion cells per infusion concurrently with FOLFIRI (combination of 5-fluorouracil, leucovorin and irinotecan) chemotherapy.