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Cullinan Therapeutics Receives U.S. FDA Clearance of Investigational New Drug Application for CLN-978 Administered Subcutaneously in Patients with Moderate to Severe Systemic Lupus Erythematosus
Cullinan Therapeutics (Nasdaq: CGEM) announced FDA clearance of its Investigational New Drug (IND) Application for CLN-978, allowing its global Phase 1 clinical trial to proceed in the U.S. for patients with moderate to severe systemic lupus erythematosus (SLE). CLN-978 is the first development stage CD19 T cell engager to receive FDA IND clearance in autoimmune diseases.
The trial will enroll patients with a SLEDAI score of 8 or greater who have had inadequate response to at least two treatments. It consists of Part A (dose escalation) and Part B (dose expansion). The primary objective is to evaluate CLN-978's safety, with secondary objectives including pharmacokinetics, B cell kinetics, immunogenicity, and clinical activity.
Cullinan Therapeutics aims to address the unmet medical need in SLE patients, as current therapies often fail to fully control disease activity and prevent long-term organ damage. CLN-978 offers a novel approach with off-the-shelf access and convenient subcutaneous dosing.
The trial will enroll patients with a SLEDAI score of 8 or greater who have had inadequate response to at least two treatments. It consists of Part A (dose escalation) and Part B (dose expansion). The primary objective is to evaluate CLN-978's safety, with secondary objectives including pharmacokinetics, B cell kinetics, immunogenicity, and clinical activity.
Cullinan Therapeutics aims to address the unmet medical need in SLE patients, as current therapies often fail to fully control disease activity and prevent long-term organ damage. CLN-978 offers a novel approach with off-the-shelf access and convenient subcutaneous dosing.
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102334026 : your supposed to be resting… doctors orders!!