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RECRUITINGPhase 1INTERVENTIONAL

A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease

A Phase 1b, Open-Label Study of CLN-978 for the Treatment of Active, Moderate to Severe Sjogren's Disease

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.

Who May Be Eligible (Plain English)

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 conditions (where your immune system attacks your own body) - Considered at high risk for thrombosis - Rapidly progressive glomerulonephritis and/or urine protein/creatinine \>3 mg/mg (339 mg/mmol). - Active, severe central nervous system manifestations of SjD. - History of stroke, seizure, dementia, Parkinson's disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder that the Investigator feels would put the patient at undue risk or confound study results. - Evidence of hepatitis B virus (HBV), hepatitis C virus (HCV), human weakened immune system virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection. - Primary weakened immune system or history of recurrent infections. - History of splenectomy. - Live or attenuated vaccine within 28 days prior to the Screening Visit or during the Screening Period. - Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, within 14 days prior to Day 1. - Active or latent tuberculosis (TB) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 high risk for thrombosis * Rapidly progressive glomerulonephritis and/or urine protein/creatinine \>3 mg/mg (339 mg/mmol). * Active, severe central nervous system manifestations of SjD. * History of stroke, seizure, dementia, Parkinson's disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder that the Investigator feels would put the patient at undue risk or confound study results. * Evidence of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection. * Primary immunodeficiency or history of recurrent infections. * History of splenectomy. * Live or attenuated vaccine within 28 days prior to the Screening Visit or during the Screening Period. * Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, within 14 days prior to Day 1. * Active or latent tuberculosis (TB)

Treatments Being Tested

DRUG

CLN-978

Specified dose on specified days

Locations (11)

Cullinan Investigative Site
Orlando, Florida, United States
Cullinan Investigative Site
Memphis, Tennessee, United States
Cullinan Investigative Site
Plano, Texas, United States
Cullinan Investigative Site
Webster, Texas, United States
Cullinan Investigative Site
Salt Lake City, Utah, United States
Cullinan Investigative Site
Brest, France
Cullinan Investigative Site
Le Kremlin-Bicêtre, France
Cullinan Investigative Site
Strasbourg, France
Cullinan Investigative Site
Erlangen, Germany
Cullinan Investigative Site
Hanover, Germany
Cullinan Investigative Site
Roma, Italy