FDA grants fast track, rare pediatric disease designations to WU-CART-007 for T-cell ALL
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The FDA granted fast track and rare pediatric disease designations to WU-CART-007 for treatment of relapsed or refractory T-cell acute lymphoblastic leukemia, according to a press release from the agent’s manufacturer.
WU-CART-007 (Wugen), an off-the-shelf, CD7-targeted chimeric antigen receptor T-cell therapy derived from healthy donor cells, uses CRISPR/Cas9 gene editing technology to knock out CD7 and T-cell receptor alpha constant, which prevents CAR T-cell fratricide and graft-versus-host disease. It is being studied for safety and efficacy as part of a global, open-label phase 1/phase 2 study among patients with relapsed or refractory T-cell ALL or T-cell lymphoblastic lymphoma.
“Earlier this year, we dosed the first patient [in the trial] and are currently in the dose-escalation phase of the study,” Dan Kemp, PhD, president and CEO of Wugen, said in the press release. “We look forward to working closely with the FDA as we continue to advance WU-CART-007 through clinical development.”
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