Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07852234

PHASE2

Exploratory Study on the Efficacy and Safety of Low-Dose Blinatumomab in the Treatment of Moderate to Severe Primary Sjögren's Syndrome

Sponsor: Beijing Tongren Hospital

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if blinatumomab works to treat moderate-to-severe primary Sjögren's Syndrome. It will also learn about the safety of low-dose blinatumomab. The main questions it aims to answer are: Is low-dose blinatumomab more effective in patients with moderate-to-severe primary Sjögren's Syndrome who have an inadequate response or intolerance to conventional treatment? How does blinatumomab affect B cells, antibody levels, and the immune system in these participants? Researchers will compare background treatment plus low-dose Blinatumomab with background treatment only to see if low-dose Blinatumomab works to treat moderate-to-severe primary Sjögren's Syndrome. Participants will: Receive background treatment for 24 weeks, including hydroxychloroquine 400 mg each day, methylprednisolone 8 mg each day, and sodium hyaluronate eye drops 4 times each day. If assigned to the blinatumomab group, receive blinatumomab by continuous intravenous infusion for 5 days during week 1 and again for 5 days during week 3. The dose will be 9 micrograms per day. Attend regular follow-up visits for clinical assessments, laboratory tests, and monitoring of treatment effectiveness and safety.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-09-25

Completion Date

2027-10-01

Last Updated

2026-10-01

Healthy Volunteers

Conditions

Primary Sjögren's Syndrome (pSS)

Interventions

DRUG

Blinatumomab

Participants will receive low-dose, short-course blinatumomab treatment. The dosing regimen is as follows: 1. First cycle: blinatumomab 9 μg/day by continuous intravenous infusion for 5 consecutive days, for a total dose of 45 μg. 2. Second cycle: the same dose and administration schedule will be repeated 1 week later.

DRUG

background treatment

All the participants will receive background treatment for 24 weeks. The background treatment includes: (1) hydroxychloroquine, 400 mg/day; (2) methylprednisolone, 8 mg/day; and (3) sodium hyaluronate eye drops, 4 times/day.

Inclusion Criteria: 1. Participants who voluntarily agree to comply with the study protocol and provide written informed consent. 2. Male or female participants aged 18 to 70 years. 3. Diagnosis of primary Sjögren's syndrome according to the 2016 ACR/EULAR classification criteria. 4. Positive anti-SSA antibody at screening. 5. Moderate-to-severe active primary Sjögren's syndrome at screening, defined as an EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score of ≥5. 6. Inadequate response or intolerance to conventional treatment, defined as having received at least one immunomodulatory therapy, including glucocorticoids, cyclophosphamide, antimalarial drugs, azathioprine, or biologic agents, for more than 6 months before screening, with unsatisfactory disease control based on ESSDAI or other clinical assessments, or recurrence of active disease after an initial treatment response. 7. Diagnosis of dry eye disease according to the 2024 Chinese Expert Consensus on the Clinical Diagnosis and Treatment of Dry Eye. 8. Moderate-to-severe dry eye disease at screening. 9. Laboratory values meeting all of the following requirements: * Absolute lymphocyte count ≥0.5 × 10⁹/L * Peripheral blood CD19+ B-cell count ≥25 cells/µL * Absolute neutrophil count ≥1.0 × 10⁹/L * Hemoglobin ≥8 g/dL * Platelet count ≥75 × 10⁹/L * Total bilirubin ≤1.5 × upper limit of normal (ULN), except for participants with confirmed Gilbert syndrome * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.0 × ULN * Estimated glomerular filtration rate ≥30 mL/min/1.73 m², calculated using the CKD-EPI equation 10. Both eyes will undergo study-related examinations and treatment. Exclusion Criteria: 1. Secondary Sjögren's syndrome. 2. Severe cardiovascular, hepatic, renal, respiratory, endocrine, or malignant disease, or uncontrolled acute or chronic infection. 3. Active and severe central nervous system manifestations related to Sjögren's syndrome. 4. History of stroke, epilepsy, dementia, Parkinson's disease, ataxia, cerebellar disease, psychosis, paresis, aphasia, or any other neurological condition that, in the investigator's judgment, may place the participant at excessive risk or interfere with study assessments. 5. Active ocular infection. 6. Other severe ocular diseases or ocular trauma diagnosed within 6 months before enrollment, including glaucoma, uveitis, retinal disease, chemical injury, or thermal burns. 7. Ocular surgery, including cataract surgery, within 6 months before enrollment. 8. Use of other eye drops that may affect the study outcomes. 9. Participation in another interventional clinical study. 10. Pregnancy or breastfeeding, or plans to become pregnant during the study period. 11. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.

Locations (1)

Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China