Cullinan Therapeutics Reports the US FDA’s IND Approval of CLN-978 to Treat Systemic Lupus Erythematosus
Shots:
- The US FDA has cleared the IND application of CLN-978 (CD19xCD3 bispecific T cell engager) to commence its P-I clinical evaluation for treating moderate to severe systemic lupus erythematosus (SLE). The company got approval to conduct its global trial across Australia in Sep
- Study will comprise of two parts, with part A finding the target dose, starting at 10μg, & part B exploring different dose schedules based on part A among patients with inadequate response to at least 2 treatments & having a SLE disease activity index score of ≥8
- The 1EP will include safety of the drug while the 2EPs will be PK profile, B cell kinetics, immunogenicity & clinical activity
Ref: Cullinan Therapeutics | Image: Cullinan Therapeutics
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
