Sjögren study: CLN-978
Official title A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease
ClinicalTrials.gov ID: NCT07041099
What this study is testing
What is CLN-978?
CLN-978 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for sjögren.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how safe and well the drug is and to observe any changes in the disease.
- Who it's for
- Adults who have active, moderate to severe Sjögren’s disease.
- What's involved
- Participants will receive injections of the drug under the skin and attend clinic visits for monitoring and tests.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- Absolute lymphocyte count (ALC) ≥0.5 × 10\^9/L
- Peripheral CD19+ B cell count ≥25 cells/µL
See the full 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.
- 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...
- 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)
The study team makes the final eligibility decision.
Where it is enrolling
- Orlando, Florida, United States
- Brooklyn, New York, United States
- Memphis, Tennessee, United States
- Plano, Texas, United States
- Webster, Texas, United States
- Salt Lake City, Utah, United States
- Brest, France
- Le Kremlin-Bicêtre, France
- Nantes, France
- Saint-Priest-en-Jarez, France
- Strasbourg, France
- Erlangen, Germany
- Hanover, Germany
- Roma, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Orlando, Florida, United States; Brooklyn, New York, United States; Memphis, Tennessee, United States; Plano, Texas, United States; Webster, Texas, United States; Salt Lake City, Utah, United States and 8 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.