Cullinan Therapeutics receives FDA IND clearance for CLN-978 in moderate-to-severe SLE

Cullinan Therapeutics, Inc.

FDA cleared IND for CLN-978, a CD19 T cell engager, in systemic lupus erythematosus.
Phase 1 trial will enroll patients with SLEDAI score ≥8 and inadequate response to ≥2 prior treatments.
Starting dose 10 mcg; Part A dose escalation, Part B dose expansion with multiple schedules.
First development-stage CD19 T cell engager to receive FDA IND clearance in autoimmune diseases.
Global trial already cleared in Australia (NCT06613360); U.S. enrollment now allowed.

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