Cullinan Therapeutics Receives US FDA Nod For phase 1 trial of CLN-978

Cullinan Therapeutics, Inc., a biopharmaceutical company specializing in developing targeted therapies, confirmed FDA approval for their Investigational New Drug Application for CLN-978. This enables the global phase 1 clinical trial in the US for assessing CLN-978 in patients with moderate to severe systemic lupus erythematosus (SLE).

The study will include participants with a SLEDAI score of eight or higher who have not responded well to at least two therapies, including one standard immunosuppressive or biologic agent. Phase A involves increasing the dosage gradually to establish the optimal dosage for future studies, commencing with an initial dosage of 10 micrograms. Phase B will involve expanding the dose by exploring various schedules based on the data collected in Phase A.

The main goal of the research is to assess the safety of CLN-978 in treating active moderate to severe SLE. Additional goals consist of pharmacokinetics, kinetics of B cells, immunogenicity, and clinical activity.

“We are pleased to continue progressing our global phase 1 clinical trial in the US with FDA clearance of our IND Application,” said Jeffrey Jones, MD, MBA, chief medical officer, Cullinan Therapeutics. “There remains a significant unmet medical need among patients with systemic lupus erythematosus, as current therapies often fail to fully control disease activity and prevent long-term organ damage. CLN-978, our novel bispecific T cell engager, targets CD19, offering a highly differentiated approach to deliver the potency of T cell redirecting therapy with off-the-shelf access and convenient dosing through subcutaneous administration."