FDA Grants Fast Track Designation to ADI-001 in Relapsed/Refractory Non-Hodgkin Lymphoma
The FDA has granted a fast track designation to the CAR T-cell therapy ADI-001 for the treatment of patients with relapsed/refractory B-cell non-Hodgkin lymphoma.
The agent is currently under exploration in the first-in-human phase 1 GLEAN-1 trial (NCT04735471) in NHL, which announced positive interim data in December 2021.
“Fast track designation represents an important milestone in the clinical development of ADI-001,” Chen Schor, president and chief executive officer of Adicet Bio, said in a news 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. 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.”
ADI-001 is an investigational allogeneic gamma delta CAR T-cell therapy that targets malignant B cells via a CD20-directed CAR and the innate gamma delta and T-cell endogenous cytotoxicity receptors. Gamma delta T cells engineered with a CD20-directed CAR have shown robust antitumor activity in preclinical models, leading to long-term disease stabilization.