CLN-978 for Sjogren's Syndrome

Recruiting at 2 trial locations

Overseen By Amy Gubits, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Cullinan Therapeutics Inc.

Disqualifiers: Rheumatological autoimmune, Thrombosis, Neurologic disorders, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CLN-978 for individuals with Sjogren's Syndrome, an autoimmune disease causing dry eyes, dry mouth, and other symptoms. The study aims to determine the right dosage and assess the treatment's safety for those with moderate to severe forms of the condition. The trial consists of two parts: one focuses on identifying the best dose, and the other evaluates further doses. Individuals with an active diagnosis of Sjogren's Syndrome for at least six months who experience significant symptoms may be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that CLN-978 is likely to be safe for humans?

Research shows that CLN-978 is in the early testing stages. Researchers are trying it in humans primarily to assess its safety and tolerability. Due to its early phase, detailed safety information remains limited. Typically, treatments in this phase undergo testing on a small group to identify side effects and establish a safe dose.

Currently, the main goal is to determine if CLN-978 is safe for individuals with Sjogren's Syndrome, an immune system disorder. Early trials aim to ensure there are no major side effects. If CLN-978 had prior approval for other conditions, it might offer insights into its safety, but this specific treatment is still under investigation. Participants in this trial will help researchers gather more information about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Sjogren's Syndrome, which often include medications like hydroxychloroquine or corticosteroids to manage symptoms, CLN-978 works differently by targeting the underlying causes of the disease. Researchers are excited about CLN-978 because it has a novel mechanism of action that could potentially modify the disease process rather than just alleviating symptoms. This new approach may offer more effective and lasting relief for patients, setting it apart from existing therapies.

What evidence suggests that CLN-978 might be an effective treatment for Sjogren's Disease?

Research has shown that CLN-978 targets B-cells, a type of immune cell often involved in autoimmune diseases like Sjogren's Syndrome. By reducing the number of these B-cells, the treatment aims to lessen disease severity. Early results suggest this method could manage symptoms more effectively. Although information on CLN-978's effectiveness in humans remains limited, its mechanism offers a promising treatment strategy. Early signs from other treatments that also reduce B-cells in autoimmune diseases support this potential benefit. Participants in this trial will receive CLN-978 in either a dose escalation phase or a further dose evaluation phase to assess its effectiveness and safety. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for people with active, moderate to severe Sjogren's Disease (SjD) who meet specific lab criteria like certain blood cell counts and liver function. They must have been diagnosed at least 24 weeks ago and not have other autoimmune diseases, high risk of thrombosis, serious neurological conditions, or recent infections including COVID-19.

Inclusion Criteria

Laboratory parameters including: 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

I was diagnosed with Sjögren's syndrome at least 6 months ago and meet specific criteria.

My disease is active and severe, scoring 5 or more on a specific scale.

Exclusion Criteria

Concomitant rheumatological autoimmune disease

Considered at high risk for thrombosis

Rapidly progressive glomerulonephritis and/or urine protein/creatinine >3 mg/mg (339 mg/mmol)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CLN-978 subcutaneously in dose escalation and further dose evaluation cohorts

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CLN-978

Trial Overview The study tests CLN-978, a new medication given under the skin for Sjogren's Disease. It's an early-phase trial to see how safe it is and how well it works in patients with significant symptoms of this condition.

How Is the Trial Designed?

Group I: Part B Further Dose Evaluation Experimental Treatment 1 Intervention

Further evaluation of CLN-978 treatment of patients with Sjogren's Disease

Group II: Part A Dose Escalation Experimental Treatment 1 Intervention

Patients with Sjogren's Disease treated with CLN-978 in dose escalation cohorts

Who Is Running the Clinical Trial?

Cullinan Therapeutics Inc.

Lead Sponsor

Trials

9

Recruited

1,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07041099

NCT07041099 | A Study of CLN-978, a Subcutaneously ... Study Overview. A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.

2. trials.arthritis.org trials.arthritis.org/trials/NCT07041099

A Study of CLN-978, a Subcutaneously Administered CD19 ... Study Purpose. A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.

3. cullinantherapeutics.com cullinantherapeutics.com/science/pipeline/

Pipeline CLN-978 is currently being studied in a global Phase 1 clinical trial in patients with active, moderate to severe Sjögren's disease. CLN-978 was developed ...

4. sjogrenssyndromenews.com sjogrenssyndromenews.com/news/upcoming-us-clinical-trial-test-cln-978-sjogrens-treatment/

Upcoming US clinical trial will test CLN-978 as Sjögren's ... A novel treatment candidate, according to Cullinan, CLN-978 aims to ease disease severity in Sjögren's by depleting B-cells. The therapy ...

5. withpower.com withpower.com/trial/phase-1-sjogrens-syndrome-8-2025-20839

CLN-978 for Sjogren's Syndrome This Phase 1 medical study run by Cullinan Therapeutics Inc. is evaluating whether CLN-978 will have tolerable side effects & efficacy for patients with ...

6. clinicaltrialsarena.com clinicaltrialsarena.com/news/cullinan-cln-978/

Cullinan Therapeutics to begin trial of drug for Sjögren's ... Its primary goal is to assess CLN-978's tolerability and safety in these subjects while its secondary objectives include evaluating the ...

7. cullinantherapeutics.com cullinantherapeutics.com/patients/clinical-trials/

Explore Cullinan's Clinical Trials OUTRACE Sjögren's This Phase 1b study of CLN-978 is evaluating safety, as well as potential effects on disease activity and the immune system. Status.