NCT07041099 · Cullinan Therapeutics Inc.
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease
What this study is about
A phase 1b, where both patients and doctors know the treatment given study of CLN-978 administered injected under the skin in patients with active, moderate to severe Sjogren's Disease.
View original scientific description
A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.
Interventions
DRUG
CLN-978
Specified dose on specified days
Primary outcome measures
Safety and Tolerability
Time frame: 48 weeks
Incidence and severity of adverse events (AEs), serious AEs (SAEs), AEs of special interest (AESIs).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 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).
- 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
- Orlando, Florida
- Brooklyn, New York
- Memphis, Tennessee
- Plano, Texas
- Webster, Texas
- Salt Lake City, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 11, 2026 · Source of record for eligibility and locations