Adicet has initiated its First-in-Human Phase I clinical trial evaluating ADI-001 for the treatment of B cell non-Hodgkin's lymphoma (NHL). ADI-001 is an investigational first-in-class allogeneic gamma delta T cell therapy expressing a chimeric antigen receptor (CAR) targeting CD20, engineered to potentially enhance selective tumor targeting, facilitate innate and adaptive anti-tumor immune response, and improve persistence for durable activity in patients.

"Initiating the Phase 1 trial represents an important milestone in the development of our lead product candidate, ADI-001, for patients with NHL, and for Adicet's emerging pipeline of "off-the-shelf" gamma delta T cell product candidates. Based on ADI-001's encouraging preclinical data, we believe our novel CAR gamma delta T cell therapy has the potential to provide an attractive treatment option for NHL patients," said Francesco Galimi, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Adicet. "We are excited to bring ADI-001 into clinical development and look forward to advancing our product pipeline to address additional solid and hematologic tumors."

Adicet's Phase I trial is an open-label, multi-center study of ADI-001 enrolling adults diagnosed with B cell malignancies who have either relapsed, or are refractory to at least two prior regimens. The primary objectives of the trial are to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ADI-001, and to determine optimal dosing as a monotherapy. A combination of ADI-001 and interleukin 2 may also be evaluated in this trial. The trial is expected to enroll approximately 75 patients, with preliminary safety and tolerability data expected by the end of 2021, subject to the impact of COVID-19.

NHL is the most common cancer of the lymphatic system, and develops in white blood cells called lymphocytes. Approximately 90% of NHL patients in western countries are diagnosed with B cell lymphomas of various types. Diffuse Large B cell lymphoma, or DLBCL, is the most common type of NHL, accounting for 30% of NHL diagnoses. Most types of NHL are incurable with available therapies, and more than 70,000 new cases of NHL are diagnosed each year in the United States.

ADI-001 is an investigational allogeneic gamma delta T cell therapy being developed as a treatment for B-cell non-Hodgkin's lymphoma (NHL). ADI-001 targets malignant B-cells via an anti-CD20 CAR and via the gamma delta T cell endogenous cytotoxicity receptors. Gamma delta T cells engineered with an anti-CD20 CAR have demonstrated potent antitumor activity in preclinical models, leading to long-term control of tumor growth.