Galapagos Receives the US FDA’s IND Clearance of GLPG5101 to Treat R/R Non-Hodgkin lymphoma (NHL)
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- Galapagos has obtained US FDA's IND approval to commence a P-I/II (ATALANTA-1) study of GLPG5101, an autologous CD19 CAR T-cell therapy for treating r/r NHL. The study is currently ongoing in Europe
- The P-I/II study of GLPG5101 (Single fixed IV dose) assessing safety and efficacy. P-I determines the dose for P-II, and the P-II study demonstrates 1EPs: ORR, 2EPs: CRR, DoR, PFS, OS, safety, PK & feasibility of decentralized manufacturing, and each enrolled patient will be monitored for 24mos.
- Galapagos' GLPG5101 is a decentralized CD19 CAR-T cell therapy candidate capable of delivering fresh, healthy cells within a median vein-to-vein time of seven days
Ref: Galapagos | Image: Galapagos
Related News:- Galapagos Reports the First Patient Dosing of GLPG3667 in the P-II Study (GALARISSO) for the Treatment of Dermatomyositis
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies. He can be contacted at connect@pharmashots.com
