FDA grants fast track designation to gamma-delta T-cell therapy for advanced lymphoma
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The FDA granted fast track designation to ADI-001 for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma.
ADI-001 (Adicet Bio) is an allogeneic gamma-delta T-cell therapy derived from donor cells that is genetically engineered to express a CD20-directed chimeric antigen receptor.
The FDA's fast track designation helps to expedite development, review and potential approval of treatments for serious or life-threatening diseases.
The investigational cell therapy is currently being evaluated as part of the GLEAN-1 trial, a phase 1, U.S.-based multicenter dose-escalation study to determine its safety and tolerability for the treatment of patients with relapsed or refractory B-cell malignancies who have received at least two prior lines of treatment.
“Fast track designation represents an important milestone in the clinical development of ADI-001,” Chen Schor, president and CEO of Adicet Bio, said in a company-issued press release.
“We believe ADI-001 is unique in that it is designed to target malignant B cells by leveraging the innate and adaptive receptors found naturally on gamma-delta T cells with the added benefit of an engineered anti-CD20 CAR,” he added. “We remain optimistic about the potential of our program and look forward to reporting additional data from the phase 1 trial of ADI-001 in the first half of 2022.”
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