A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease
Not Applicable
Recruiting
- Conditions
- SjögrenSjogren DiseaseSjogren's Syndrome
- Interventions
- Registration Number
- NCT07041099
- Lead Sponsor
- Cullinan Therapeutics Inc.
- Brief Summary
A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A Dose Escalation CLN-978 Patients with Sjogren's Disease treated with CLN-978 in dose escalation cohorts Part B Further Dose Evaluation CLN-978 Further evaluation of CLN-978 treatment of patients with Sjogren's Disease
- Primary Outcome Measures
Name Time Method Safety and Tolerability 48 weeks Incidence and severity of adverse events (AEs), serious AEs (SAEs), AEs of special interest (AESIs).
- Secondary Outcome Measures
Name Time Method To evaluate the PK of CLN-978 48 wks Serum concentrations of CLN-978
Detection of anti-drug antibodies 48 weeks Detection of anti-drug antibodies
Pharmacodynamics-related biomarker 48 weeks B lymphocyte cell numbers and change from baseline in peripheral blood
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does CLN-978 utilize to target CD19 in Sjogren's Disease patients?
How does CLN-978's subcutaneous administration compare to standard-of-care treatments for moderate to severe Sjogren's Syndrome in terms of efficacy and safety?
Which biomarkers are being evaluated for patient selection and response prediction in the Cullinan Therapeutics NCT07041099 trial?
What are the potential adverse events associated with CD19-directed T cell engagers like CLN-978 in autoimmune diseases?
Are there any combination therapies or competitor drugs targeting B cells in Sjogren's Disease similar to CLN-978's mechanism?
Trial Locations
- Locations (1)
Cullinan Investigative Site
🇺🇸Plano, Texas, United States
Cullinan Investigative Site🇺🇸Plano, Texas, United States