A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subject
A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.
| Condition(s) | Sjögren, Sjogren Disease, Sjogren's Syndrome |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease. |
| Who can participate | Inclusion * Diagnosis of SjD at least 24 weeks prior to Screening Visit and meet the 2016 EULAR / ACR Classification Criteria for SjD at Screening. * Have active moderate to severe disease (i.e., ESSDAI ≥5) at Screening. * Laboratory parameters including the following: * Absolute lymphocyte count (ALC) ≥0.5 × 10\^9/L * Peripheral CD19+ B cell count ≥25 cells/µL * Absolute neutrophil count (ANC) ≥1.0 × 10\^9/L * Hemoglobin (Hgb) ≥8 g/dL * Platelet count ≥75 × 10\^9/L * Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.0 × ULN * Estimated glomerular filtration rate (eGFR) based on the CKD-EPI formula ≥30 mL/min/1.73 m2 Exclusion * Concomitant rheumatological autoimmune disease * Considered at |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Cullinan Therapeutics Inc. |
| Locations | Orlando, Florida, United States; Memphis, Tennessee, United States; Plano, Texas, United States; Webster, Texas, United States; Salt Lake City, Utah, United States; Brest, France (+5 more sites) |
| Start date | 2025-10-01 |
| NCT ID | NCT07041099 |
| Official listing | https://clinicaltrials.gov/study/NCT07041099 |