FDA clears IND application for off-the-shelf, BCMA-directed CAR-T for advanced myeloma
The FDA cleared an investigational new drug application for CYAD-211, a chimeric antigen receptor T-cell therapy for the treatment of relapsed or refractory multiple myeloma, according to a press release from the agent’s manufacturer.
CYAD-211 (Celyad Oncology) is an allogeneic CAR T-cell therapy that targets the B-cell maturation antigen (BCMA) on the surface of cancer cells. The investigational therapy — which is not gene-edited — uses Celyad’s proprietary short hairpin RNA (shRNA)-based allogeneic CAR-T.
The therapy was developed to co-express a BCMA-targeted CAR and a single shRNA to interfere with the expression of the CD3-zeta component of the T-cell receptor complex.
The FDA clearance will allow Celyad to initiate a phase 1 trial to assess the safety and feasibility of CYAD-211 for adults with relapsed or refractory multiple myeloma.
“The FDA’s permission to begin the phase 1 clinical trial of our lead shRNA-based allogeneic candidate is a watershed moment for our organization,” Filippo Petti, CEO of Celyad Oncology, said in the press release.
“We are excited to have the CYAD-211 IND in effect to initiate the phase 1 trial by year-end 2020 for this first-in-class CAR-T candidate for patients with multiple myeloma and look forward to accelerating the development of additional shRNA-based allogeneic candidates from our CYAD-200 series toward clinical trials,” he added.
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