The FDA has cleared an investigational new drug application for ADI-001, a first-in-class allogeneic chimeric antigen receptor gamma-delta T-cell therapy for the treatment of patients with non-Hodgkin lymphoma, according to a press release from the manufacturer. 

The clearance allows the manufacturer to initiate the first-in-human clinical trial to assess the safety and efficacy of the CD20 targeted therapy. 

“The clearance of the IND for ADI-001 by the FDA is a significant milestone in the development of CAR [gamma-delta] T cell therapies by Adicet, and marks the beginning of clinical development of a deep pipeline of “off-the-shelf” [gamma-delta] T cell products,” Chen Schor, president and CEO of Adicet, said in a press release. “We are particularly excited to advance on our goal to exploit the therapeutic potential of our first in class engineered CAR [gamma-delta]  T cell therapy in NHL patients. We believe that ADI-001 offers the opportunity for on demand treatment, selective tumor targeting, innate and adaptive anti-tumor immune response, and durable activity in patients.”

The clinical trial aims to enroll up to 80 patients with late stage NHL. The study will include both a dose finding portion and a dose expansion portion. 

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 tumor growth,” according to the press release. Additional data for ADI-001 are expected in 2021.