Date: 2018-07-24
Type of
information: Clinical trial authorisation
phase: 1
Announcement: clinical trial authorization
Company: Celyad (Belgium)
Product: CYAD-101
Action
mechanism:
- cell therapy/immunotherapy product/gene therapy/CAR-T cell therapy. CYAD-101, Celyad’s first allogeneic CAR-T cell product, encodes both the company’s autologous CYAD-01 CAR-T and a novel peptide, TIM (TCR Inhibiting Molecule), an inhibitor of TCR signaling. TCR signaling is responsible for the Graft versus Host Disease (GvHD), and tampering or eliminating its signaling could therefore reduce or eliminate GvHD. In CYAD-101, the TIM peptide is encoded alongside the CAR construct allowing allogeneic T cell production through a single transduction step. CYAD-101 benefits from using a manufac-turing process that is highly similar to Celyad’s well established process for its clinical au-tologous CAR-T cell products.
Disease: unresectable colorectal cancer
Therapeutic
area: Cancer - Oncology
Country:
Trial
details:
Latest
news:
- • On July 24, 2018, Celyad announced that the FDA has accepted the company’s Investigational New Drug (IND) application for CYAD-101, the first non-gene edited allogeneic clinical program. The FDA has indicated that the Allo-SHRINK trial, evaluating the safety and clinical activity of CYAD-101 in patients with unresectable colorectal cancer in combination with standard chemotherapy, is allowed to proceed.
- While autologous CAR-T therapies now have well established efficacy in B cell malignancies, the approach can be more challenging for some patients, especially those where the quality of the apheresis is poor. Allogeneic CAR-T cell therapy may provide an alternative approach for this patient population, utilizing cells manufactured from a healthy donor which could allow greater reproducibility and reduced manufacturing costs.
Is
general: Yes
