Company: GLPG
Filing Date: 2025-03-27
Form Type: 20-F
Source: 0001558370-25-003806
Chunk: 109

Company: GALAPAGOS NV
Filing Date: 2025-03-27
Form: 20-F
Item: Item 4
Chunk 109
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"><{self.tag} alt="{self.alt}" src="{self.src}"><{self.tag} alt="{self.alt}" src="{self.src}"><{self.tag} alt="{self.alt}" src="{self.src}"><{self.tag} alt="{self.alt}" src="{self.src}"><{self.tag} alt="{self.alt}" src="{self.src}"><{self.tag} alt="{self.alt}" src="{self.src}">GLPG5201 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose. The safety, efficacy and feasibility of decentralized manufactured GLPG5201 were evaluated in the EUPLAGIA-1 Phase 1/2, open-label, multicenter study in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL), small cell lymphocytic lymphoma (R/R SLL), and Richter transformation (RT).
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Patients with CD19+ R/R CLL or R/R SLL with >2 lines of therapy are eligible to participate, and patients with RT are eligible regardless of prior therapy. The primary objective of the Phase 1 part of the study is to evaluate safety and determine the recommended dose for the Phase 2 part of the study. The dose levels that are evaluated in the Phase 1 part of the study are 35x106 (DL1) and 100x106 (DL2) CAR+ viable T cells. 
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The primary objective of the Phase 2 part of the study is to assess the ORR and the secondary objectives including the analysis of the CRR, duration of response, progression free survival, overall survival, safety pharmacokinetic profile, and feasibility of decentralized manufacturing.
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In December 2024, we presented initial encouraging safety and efficacy encore data from the EUPLAGIA-1 Phase 1/2 study during a poster session at the 2024 Annual Meeting of the American Society of Hematology (ASH) Meeting. 
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As of the data cut-off on February 21, 2024, patient recruitment of the Phase 1 dose-finding part of EUPLAGIA-1 has been completed and, 15 patients (6 at dose level 1 (DL1); and 9 at dose level 2 (DL2)) were enrolled, all of whom were diagnosed with R/R CLL, and 9 with additional RT. All