US FDA okays phase 1 study of gamma delta T cell therapy for non-Hodgkin’s lymphoma

US FDA okays phase 1 study of gamma delta T cell therapy for non-Hodgkin’s lymphoma

The FDA has recently approved the investigational new drug (IND) application for ADI-001, an allogeneic gamma delta (γδ) T cell therapy for the treatment of for B-cell non-Hodgkin’s lymphoma (NHL), announced the biotechnology company Adicet.

ADI-001 targets malignant B-cells via an anti-CD20 chimeric antigen receptor (CAR) and via the gamma delta T cell endogenous cytotoxicity receptors. Gamma delta T cells engineered with an anti-CD20 CAR have demonstrated highly potent antitumor activity in preclinical models, leading to effective long-term control of tumour growth. The FDA clearance was based on the data from the preclinical studies.

Moreover, data from preclinical models presented at the 2019 American Society of Gene and Cell Therapy Annual Meeting showed no evidence of graft-versus-host disease.

The phase 1 study for ADI-001 will enrol up to 80 late-stage non-Hodgkin’s lymphoma patients at a number of cancer centres across the US. The study includes a dose-finding portion followed by dose expansion cohorts to explore the activity of ADI-001 in multiple subtypes of NHL. Site initiation activities are underway and interim clinical data from this study are expected in 2021.

“This is a significant milestone in the development of CAR gamma-delta T-cell therapies, and marks the beginning of clinical development of a deep pipeline of ‘off-the-shelf’ gamma-delta T-cell products,” said Chen Schor, president and CEO of Adicet.