Cullinan Therapeutics, Inc. announced on October 16, 2024, that the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) Application for CLN-978. This clearance allows the company to proceed with a global Phase 1 clinical trial in the U.S. to evaluate CLN-978 in patients with moderate to severe systemic lupus erythematosus (SLE). CLN-978 is a novel, highly potent CD19xCD3 bispecific T cell engager.
The trial will enroll patients with a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of eight or greater who have had an inadequate response to at least two prior treatments. Part A of the study is a dose escalation phase, starting with a 10 microgram dose, to determine the target dose for further development. Part B will be a dose expansion phase exploring multiple dose schedules.
This FDA clearance is a critical step for Cullinan, as CLN-978 is the first development-stage CD19 T cell engager to receive U.S. FDA IND clearance in autoimmune diseases. The company previously received clearance to initiate this global clinical trial in Australia in September 2024, highlighting its international development strategy for this asset.
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