CM336 for Active Sjogren's Syndrome Study

NCT07642843 | Not Yet Recruiting Phase 1

• 1 other identifier: CM336-127001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CM336 in adult participants with active primary Sjogren's Syndrome.

Conditions

Primary Sjögren's Syndrome (pSS)

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Throughout study (Up to 52 weeks)

Study Arms (1)

CM336 dose escalation

EXPERIMENTAL

Biological: CM336

Interventions

CM336 BIOLOGICAL

Participants will receive CM336 via subcutaneous injection in ascending dose cohorts

CM336 dose escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF), and willing to comply with the study protocol requirements.
• Body weight ≥ 45 kg at screening.
• Voluntary compliance with the protocol requirements for permitted/prohibited concomitant therapies.
• Definitive diagnosis of primary Sjögren's disease (SjD) according to the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria, and meeting all of the following requirements:
• Seropositive for at least one SjD-related autoantibody.
• Prior treatment with at least two systemic therapies for SjD symptoms.
• Active disease at screening, defined as Clinical EULAR Sjögren's Syndrome Disease Activity Index(ClinESSDAI) ≥ 5.
• No better therapeutic alternative available for the study participant.

You may not qualify if:

• Presence of other systemic autoimmune diseases besides primary Sjögren's disease.
• Presence of other autoimmune or inflammatory diseases.
• Presence of any other medical condition with clinical manifestations overlapping with primary Sjögren's disease or that may interfere with result interpretation.
• Presence of active, life-threatening, or organ-threatening SjD complications at screening.
• History of severe allergic reactions (as judged by the investigator), or history of hypersensitivity to monoclonal antibodies or any component of CM336.
• Presence of congenital immunodeficiency, or acquired immunodeficiency not related to the participant's autoimmune disease or its medical treatment.
• Positive HIV antibody, positive Treponema pallidum antibody, or history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• History of tuberculosis infection.
• Active infection requiring intravenous anti-infective treatment within 3 months before first dose of study drug, or oral anti-infective treatment within 2 weeks before first dose of study drug.
• History of disseminated herpes zoster, or ocular/Central Nervous System herpes zoster, or systemic herpes simplex or symptomatic herpes zoster infection within 3 months before first dose of study drug.
• Deep vein thrombosis or pulmonary embolism within 6 months before first dose of study drug.
• History of severe cardiovascular or cerebrovascular disease, including but not limited to:
• Unstable arrhythmia, unstable angina pectoris.
• New York Heart Association (NYHA) functional class III or IV.
• Uncontrolled hypertension (average systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg on two measurements despite optimal treatment).

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Central Study Contacts

Qian Jia

CONTACT

86+028-88610620; clinicaltrial@keymedbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

CN (1)