Clinical TrialJun 8, 2026, 06:36 AM
Cullinan Therapeutics Presents Positive Phase 1 Data for CLN-978 in RA and SLE
AI Summary
Cullinan Therapeutics announced initial clinical data from its Phase 1 OUTRACE trials for CLN-978, a CD19xCD3 T cell engager, in patients with treatment-refractory rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). The data, presented at EULAR 2026, showed clinical benefit including remissions in both patient groups, deep and dose-dependent B cell depletion, and a favorable safety profile. The company also announced an upcoming Immunology Day to present further data.
Key Highlights
- Cullinan Therapeutics presented initial Phase 1 data for CLN-978 in treatment-refractory rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE).
- In SLE patients (n=14 with >=4 weeks follow-up), 71% (10/14) showed >=4-point reduction in hSLEDAI, with 5 achieving DORIS remission.
- In RA patients (n=7), 71% (5/7) improved disease activity, with one patient achieving DAS28-ESR remission.
- CLN-978 demonstrated dose-dependent B cell depletion (>80% reduction in 82% of SLE patients, 67% BLOQ at >=20 µg in RA patients).
- Safety profile was favorable; 38% (11/29) experienced Grade 1 CRS, with one Grade 3 CRS at 45 µg.
- No immune effector cell-associated neurotoxicity syndrome (ICANS) was observed.
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