The US Food and Drug Administration (FDA) has granted clearance for Galapagos’ investigational new drug (IND) application to commence the Phase I/II ATALANTA-1 study of GLPG5101 for relapsed/refractory non-Hodgkin lymphoma (r/r NHL).
The multicentre trial aims to evaluate the feasibility, safety, and efficacy of GLPG5101 in r/r NHL patients.
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GLPG5101 is a new CD19 chimeric antigen receptor (CAR)-T cell therapy and is designed to be administered as a single fixed intravenous dose.
The therapy is produced using Galapagos’ decentralised cell therapy manufacturing platform. This approach potentially allows for the administration of fresh, fit cells within a median vein-to-vein time of just seven days.
Assessing the safety and initial efficacy of GLPG5101 to determine the recommended dose for Phase II is the primary goal of the Phase I portion of the trial.
Evaluating the efficacy and feasibility of decentralised manufacturing of GLPG5101 are the secondary objectives.
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By GlobalDataFor the Phase II part of the trial, the primary goal is to evaluate the objective response rate.
Secondary objectives encompass the complete response rate, progression-free survival, duration of response, overall survival, safety, pharmacokinetics and feasibility of decentralised manufacturing.
Each enrolled trial subject will be followed for 24 months, the company noted.
Galapagos CEO and board of directors chairman Dr Paul Stoffels said: “We are dedicated to accelerating breakthrough innovation that extends the reach of cell therapies to patients with rapidly progressing cancers.
“Our innovative, decentralised manufacturing platform is designed to overcome many of the challenges faced by existing CAR-T production methods.
“The IND clearance for the Phase I/II study of GLPG5101 marks a significant milestone in our cell therapy clinical programme, bringing us one step closer to offering our CD19 CAR-T cell therapy to patients in the US.”
Last August, the company randomised the first patient in the Phase II GALACELA trial of the GLPG3667 drug to treat systemic lupus erythematosus.
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