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     138  0 Kommentare 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.

    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.

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    Celyad Oncology Presents Data Update from Phase 1 alloSHRINK Trial for CYAD-101 in mCRC at ASCO-GI Symposium - Seite 2 Regulatory News: Celyad Oncology SA (Brussels:CYAD) (Paris:CYAD) (NASDAQ:CYAD) (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for …