Cullinan Therapeutics to present preclinical data for CLN-978

Cullinan Therapeutics (CGEM) will present new preclinical data for CLN-978, its novel CD19xCD3 T cell engager. These data and the study schema for a planned Phase 1b study in patients with moderate to severe systemic lupus erythematosus will be presented at the annual meeting of the American College of Rheumatology, ACR Convergence 2024, being held in Washington, D.C., November 14-19. These data will be shared in a poster presentation on November 16, 2024, 10:30 a.m.-12:30 p.m. Eastern Time. Cullinan will also have a Booth in the Exhibit Hall. CLN-978 Preclinical Data: New in vitro preclinical data show CLN-978 induced similar T cell activation, target B cell depletion, and cytokine production in human peripheral blood mononuclear cells derived from patients with SLE or rheumatoid arthritis as compared to healthy volunteers. These studies collectively suggest that the previously observed cytokine window observed in B-NHL model systems, potentially resulting in a broad therapeutic index, is expected to be preserved in SLE and RA patients. In October, Cullinan Therapeutics announced U.S. Food and Drug Administration clearance of an Investigational New Drug Application for its global Phase 1 clinical trial to evaluate CLN-978 for the treatment of patients with moderate to severe SLE to proceed in the United States. Cullinan previously announced Human Research Ethics Committee approval to initiate the global clinical trial in Australia. The trial will enroll patients with a Systemic Lupus Erythematosus Disease Activity Index score of eight or greater and who have had an inadequate response to at least two treatments, including one immunosuppressive or biologic standard-of-care agent. Part A is a dose escalation phase using a modified single-ascending dose design to determine a recommended target dose for further development. Part A is planned to explore target dose levels of 10, 20, 30, and 45 micrograms in a stepwise ascending fashion, enrolling at least three patients in each cohort. Dose levels above 10 mcg will incorporate a step-up dose of 10 mcg administered on Day 1 followed by administration of the higher cohort target dose on Day 8. Part B is a dose expansion phase which will explore two or more recommended dose schedules informed by data from Part A of the study. The primary objective of the study is to evaluate the safety of CLN-978 for treatment of active moderate to severe SLE. Secondary objectives include pharmacokinetics, B cell kinetics, immunogenicity, and clinical activity. Initial clinical data are expected in the fourth quarter of 2025.