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, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
