SjögrenPhase 1NCT07041099
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease
A Phase 1 study testing CLN-978 in people with Sjögren and Sjogren Disease, run by Cullinan Therapeutics Inc. at 14 sites in 4 countries.
Trial summary
A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjögren, Sjogren Disease, Sjogren's Syndrome
- What is being tested?
- CLN-978
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 1 Oct 2025to 15 Mar 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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)
Trial locations and contacts
14 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 4 countries
United States6 sites, 6 recruiting
- Recruiting
New York University
Brooklyn, New York, 11201
Abraham Sinay-Smith, abraham.sinay-smith@nyulangone.org
- Recruiting
Regional One
Memphis, Tennessee, 38103
Lisa McKnight, 901-633-2531, Lismith@regionalonehealth.org
- Recruiting
Omega Research
Orlando, Florida, 32808
Kwabena Ayesu, MD, 407-512-1054, kayesu@omegarcllc.com
- Recruiting
Stryde Research
Plano, Texas, 75093
Mariana Paz, 214-884-7787, mpaz@stryderesearch.com
- Recruiting
Intermountain
Salt Lake City, Utah, 84143
Joshua Kunz, 801-408-4724, Joshua.kunz@imail.org
- Recruiting
Tranquil Research
Webster, Texas, 77598
Karim Mohammed, 713-907-6054, sc@tranquilityresearch.com
France5 sites, 5 recruiting
- Recruiting
CHU Brest
Brest, 29609
Divi Cornec, MD, 02 98 34 73 60, divi.cornec@chu-brest.fr
- Recruiting
Hopitaux Universitaires Paris-Sud
Le Kremlin-Bicêtre, 94270
Xavier Mariette, MD, 01 45 21 37 58, xavier.mariette@aphp.fr
- Recruiting
CHU Nantes
Nantes, 44093
Antoine Néel, MD, 02 40 08 33 55, antoine.neel@chu-nantes.fr
- Recruiting
CHU St.-Étienne
Saint-Priest-en-Jarez, 42270
Martin Killian, MD, 04 77 82 91 79, martin.killian@chu-st-etienne.fr
- Recruiting
CHU Strasbourg-Hautepierre
Strasbourg, 67098
Jacques-Eric Gottenberg, MD, 03 88 12 74 22, jacques-eric.gottenberg@chru-strasbourg.fr
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Erlangen
Erlangen, 91054
Ricardo Grieshaber Bouyer, MD, ricardo.grieshaber@uk-erlangen.de
- Recruiting
Hannover Medical School
Hanover, 30625
Torsten Witte, MD, rht-studienambulanz@mh-hannover.de
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A Gemelli
Roma, 00168
Giulia Wlderk, 39 06 30159650, reumatrial@policlinicogemelli.it
About this study
Official title: A Phase 1b, Open-Label Study of CLN-978 for the Treatment of Active, Moderate to Severe Sjogren's Disease
A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.
- Conditions
- Sjögren, Sjogren Disease, Sjogren's Syndrome
- Being tested
- CLN-978
- Keywords
- CLN-978
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLN-978Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A Dose Escalation | Experimental | Patients with Sjogren's Disease treated with CLN-978 in dose escalation cohorts Receives: Drug: CLN-978 |
| Part B Further Dose Evaluation | Experimental | Further evaluation of CLN-978 treatment of patients with Sjogren's Disease Receives: Drug: CLN-978 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Incidence and severity of adverse events (AEs), serious AEs (SAEs), AEs of special interest (AESIs).
Measured: 48 weeks
Secondary outcomes (3)
To evaluate the PK of CLN-978
Serum concentrations of CLN-978
Measured: 48 weeks
Detection of anti-drug antibodies
Detection of anti-drug antibodies
Measured: 48 weeks
Change from baseline in B lymphocyte cell numbers in peripheral blood
B lymphocyte cell numbers and change from baseline in peripheral blood
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Oct 2025
- Primary completion15 Mar 2028 (estimated)
- Study completion15 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SjögrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cullinan Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041099
- Sponsor's protocol ID
- CLN-978-SJ-101
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-Label Study of CLN-978 for the Treatment of Active, Moderate to Severe Sjogren's Disease
- ClinicalTrials.gov ID
- NCT07041099
- Acronym / sponsor ID
- CLN-978-SJ-101
- Conditions
- Sjögren, Sjogren Disease, Sjogren's Syndrome
- Keywords
- CLN-978
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cullinan Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 15 Mar 2028 (estimated)
- Study completion
- 15 Mar 2029 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A Dose Escalation | Experimental | Drug: CLN-978Patients with Sjogren's Disease treated with CLN-978 in dose escalation cohorts |
| Part B Further Dose Evaluation | Experimental | Drug: CLN-978Further evaluation of CLN-978 treatment of patients with Sjogren's Disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLN-978Specified dose on specified days | Drug | Part A Dose Escalation, Part B Further Dose Evaluation |
Primary outcome
Safety and Tolerability
Time frame: 48 weeks
Incidence and severity of adverse events (AEs), serious AEs (SAEs), AEs of special interest (AESIs).
3 secondary outcomes
To evaluate the PK of CLN-978
Time frame: 48 weeks
Detection of anti-drug antibodies
Time frame: 48 weeks
Change from baseline in B lymphocyte cell numbers in peripheral blood
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CLN-978 in people with Sjögren and Sjogren Disease, run by Cullinan Therapeutics Inc. at 14 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, France, Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Gubits, MPH (+1 617 410 4650, ClinOps@cullinantx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.