Read more

July 15, 2020
1 min read
Save

FDA clears IND application for off-the-shelf, BCMA-directed CAR-T for advanced myeloma

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

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.