RightFit
RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests CLN-978 in people with active, moderate to severe Sjogren's disease. The study drug is given as a shot under the skin.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You were diagnosed with Sjogren's disease at least 24 weeks before screening and meet the study's diagnosis rules.
  • Your disease is active and moderate to severe, with a disease activity score of at least 5.
  • Your blood tests meet the minimum levels for lymphocytes, B cells, and neutrophils, which are types of white blood cells.
  • Your hemoglobin, which carries oxygen in blood, is at least 8 g/dL. Your platelet count, which helps blood clot, is at least 75 billion/L.
  • Your bilirubin level is no more than 1.5 times the upper normal limit, unless you have confirmed Gilbert's syndrome.
  • Your liver enzyme levels, called AST and ALT, are no more than twice the upper normal limit.
  • Your kidney filtering test, called eGFR, is at least 30 mL/min/1.73 m².

Who can't join

  • You have another rheumatic autoimmune disease, where the immune system attacks joints or other body tissues, or a high risk of blood clots.
  • You have kidney inflammation that is getting worse quickly, or a urine protein-to-creatinine ratio above 3 mg/mg.
  • You have active, severe effects of Sjogren's disease on your brain or spinal cord.
  • You have a history of stroke, seizures, dementia, Parkinson's disease, psychosis, weakness, trouble speaking, or certain movement or coordination disorders. Other nerve or brain disorders may also rule you out if the study doctor thinks they pose a risk or affect results.
  • Tests show infection with hepatitis B, hepatitis C, HIV, Epstein-Barr virus, or cytomegalovirus, or you have active or inactive tuberculosis (TB).
  • You have a primary immune deficiency, meaning your immune system does not work properly, repeated infections, or a history of spleen removal.
  • You received a live or weakened-live vaccine within 28 days before screening or during screening.
  • You have an active infection that is medically significant, including COVID-19, within 14 days before the first study day.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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)

Study sites (6)

FL

NY

TN

TX

UT