Speedbul schreef op 24 november 2019 03:20:
NEW Clinical Trial:
Study in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients to Determine the Recommended Dose of CYAD-02 (CYCLE-1)
clinicaltrials.gov/Celyad registered on 20/11/2019 into the "clinical trials" data base, a NEW trial called "CYCLE-01". This trial deals specifically for AML / MDS patients INCLUDING pre-conditioning - 2 sites in the US including Mayo Clinic in Florida and 3 sites in Belgium.
With this trial registration which will include up to 27 patients, Celyad indicates already the next phase by testing CYAD-02 using ShRNA and OptimAb process.
" Candidate shRNA (from HORIZON) were screened for efficient targeting of both MICA and MICB at the mRNA and protein level. T-cells transduced with a single vector encoding for the NKG2D-based CAR and the selected shRNA targeting MICA and MICB (CYAD-02) demonstrated 3-fold increased expansion during in vitro culture in the absence of the blocking antibody used to increase cell yield during manufacture. When injected into immunosuppressed mice, CYAD-02 cells generated with the Optimab process showed 10-fold higher engraftment one week after injection and potent anti-tumor activity resulting in 2.6-fold increase of mouse survival in an aggressive AML model.". (see poster 3931 that will be presented at ASH on Monday 9/12).
Celyad already received the IND from the FDA (in June 2019)