regulatory
confidence high
sentiment positive
materiality 0.55
Cullinan Therapeutics receives Australian HREC approval to start Phase 1 SLE trial of CLN-978
Cullinan Therapeutics, Inc.
- HREC approval in Australia to initiate global Phase 1 trial of CLN-978 for systemic lupus erythematosus (SLE).
- CLN-978 is a CD19xCD3 bispecific T cell engager designed for off-the-shelf access and convenient dosing.
- SLE affects ~430,000 people globally; current treatments rarely induce treatment-free remission.
- Company also submitted IND to U.S. FDA for this study on September 16, 2024.
- Trial will assess safety, pharmacokinetics, and initial clinical activity in multiple countries.