CLN-978 injections for people with moderate to severe Sjögren's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label phase 1b study gives subcutaneous doses of CLN-978, a CD19-directed T cell engager, to adults with active moderate-to-severe Sjögren's disease to characterize safety, tolerability, pharmacokinetics, and early signs of clinical effect. Eligible participants must have a diagnosis meeting the 2016 EULAR/ACR criteria, at least 24 weeks since diagnosis, an ESSDAI score of 5 or greater, and meet specific laboratory thresholds including peripheral CD19+ B cell counts. Key exclusions include concomitant other rheumatologic autoimmune diseases, high thrombotic risk, rapidly progressive glomerulonephritis or heavy proteinuria, and active severe central nervous system manifestations. Dosing and follow-up visits are conducted at Cullinan investigative sites in the United States.

Why it matters

Who can join: the full rules

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)

Where it's running

• Omega Research
  Orlando, Florida, United States Recruiting
• New York University
  Brooklyn, New York, United States Recruiting
• Regional One
  Memphis, Tennessee, United States Recruiting
• Stryde Research
  Plano, Texas, United States Recruiting
• Tranquil Research
  Webster, Texas, United States Recruiting
• Intermountain
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Study coordinator: Amy Gubits, MPH
• Email: ClinOps@cullinantx.com
• Phone: +1 617 410 4650

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.