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2020-10-29T06:46:51.000Z

FDA clears investigational new drug application for ADI-001

Oct 29, 2020
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On October 22, 2020, the U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for ADI-001, a first-in-class allogeneic chimeric antigen receptor (CAR) gamma-delta T-cell therapy.

A first-in-human clinical trial can now be initiated to evaluate the safety and efficacy of ADI-001 in patients with non-Hodgkin lymphoma (NHL). The phase I study will involve a dose-finding portion and subsequent dose-expansion cohorts, enrolling up to 80 patients with late-stage NHL across the US. The interim results are to be expected in 2021.

ADI-001

ADI-001 is an investigational therapy that comprises allogeneic gamma-delta T cells with an anti-CD20 CAR domain. ADI-001 was designed to treat patients with B-cell NHL and can be manufactured consistently. The therapy has demonstrated highly potent antitumor activity and no evidence of graft-versus-host disease in preclinical models.

  1. Healio. FDA clears application for CAR gamma-delta T-cell therapy for advanced lymphoma. https://www.healio.com/news/hematology-oncology/20201023/fda-clears-application-for-car-gammadelta-tcell-therapy-for-advanced-lymphoma. Published Oct 23, 2020. Accessed Oct 27, 2020. 

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