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FDA clears investigational new drug application for ADI-001
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.
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In your experience, what is the average vein-to-vein time when treating patients with DLBCL with a reimbursed CAR T-cell therapy (from apheresis to infusion)?