FDA clears application for CAR gamma-delta T-cell therapy for advanced lymphoma
The FDA cleared an investigational new drug application for ADI-001, a an allogeneic chimeric antigen receptor gamma-delta T-cell therapy for the treatment of relapsed or refractory non-Hodgkin lymphoma.
ADI-001 (Adicet Bio) targets the CD20 protein on the surface of cancer cells.
“[This 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 company-issued 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 [patients with] NHL,” he added. 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.”
The FDA based the clearance on preclinical data, which showed ADI-001 could be manufactured consistently, led to in vivo expansion and demonstrated anti-tumor activity.
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 IND clearance allows Adicet to start enrollment in a phase 1, U.S.-based multicenter trial to evaluate the safety and efficacy of ADI-001 for patients with relapsed or refractory NHL. Investigators will enroll up to 80 patients with late-stage disease, and numerous disease subtypes will be assessed. The study will include dose-finding and dose-expansion components.
Adicet officials expect to report interim clinical data from the trial in 2021.
Reference:
- Romero J, et al. Abstract 871. Presented at: ASGCT Annual Meeting; April 29-May 2, 2019; Washington, D.C.
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