NCT06613360

A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus

A Phase 1b, Open-label, Pilot Study of CLN-978 for the Treatment of Moderate to Severe Systemic Lupus Erythematosus (SLE)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Cullinan Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).

Conditions

• SLE
• SLE (Systemic Lupus)

Interventions

Type	Name	Description
DRUG	CLN-978	Specified dose on specified days

Timeline

• Start date: 2025-01-21
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2024-09-25
• Last updated: 2026-03-19

Locations

15 sites across 5 countries: United States, Australia, Bulgaria, Georgia, Moldova

Regulatory

• FDA-regulated drug study