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New drug CLN-978 tested for Sjogren's sufferers

NCT ID NCT07041099

Disease control Sponsor: Cullinan Therapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This early-stage trial is testing a new drug called CLN-978 in 36 adults with active, moderate to severe Sjogren's disease. The main goal is to see if the drug is safe and tolerable, while also checking how it affects immune cells in the blood. Participants receive the drug as a shot under the skin.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CLN-978
What this could lead to
If successful, this could point toward a new treatment option for people with active, moderate to severe Sjogren's disease.
What could go wrong
This is an early phase 1 trial with only 36 participants, so it is primarily testing safety and dosing. It may not lead to an effective treatment, and side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Sjogren syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sjogren disease Sjogren's syndrome Sjögren

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    14 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Brest

    RECRUITING

    Brest, 29609, France

  • CHU Nantes

    RECRUITING

    Nantes, 44093, France

  • CHU St.-Étienne

    RECRUITING

    Saint-Priest-en-Jarez, 42270, France

  • CHU Strasbourg-Hautepierre

    RECRUITING

    Strasbourg, 67098, France

  • Fondazione Policlinico Universitario A Gemelli

    RECRUITING

    Roma, 00168, Italy

    Contact Email: •••••@•••••

  • Hannover Medical School

    RECRUITING

    Hanover, 30625, Germany

  • Hopitaux Universitaires Paris-Sud

    RECRUITING

    Le Kremlin-Bicêtre, 94270, France

  • Intermountain

    RECRUITING

    Salt Lake City, Utah, 84143, United States

  • New York University

    RECRUITING

    Brooklyn, New York, 11201, United States

  • Omega Research

    RECRUITING

    Orlando, Florida, 32808, United States

  • Regional One

    RECRUITING

    Memphis, Tennessee, 38103, United States

  • Stryde Research

    RECRUITING

    Plano, Texas, 75093, United States

  • Tranquil Research

    RECRUITING

    Webster, Texas, 77598, United States

  • University Hospital Erlangen

    RECRUITING

    Erlangen, 91054, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.