Actively Recruiting
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Rheumatoid Arthritis
Led by Cullinan Therapeutics Inc. · Updated on 2025-07-04
37
Participants Needed
2
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase I, open-label study of CLN-978 in patients with treatment-refractory rheumatoid arthritis.
CONDITIONS
Official Title
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of rheumatoid arthritis fulfilling the 2010 ACR/EULAR Classification Criteria at least 12 weeks before screening
- Evidence of B-cell-driven disease by seropositivity for RF and/or AMPA or synovial biopsy showing B-cell infiltration
- Active rheumatoid arthritis with DAS28 - ESR of 3.2 or higher and at least one swollen joint at screening
- Inadequate response to at least two targeted treatments with different mechanisms, including tsDMARD and/or bDMARD, after failing conventional synthetic DMARD unless contraindicated
- Local lab tests meeting criteria: ALC 60.5 x 10^9/L, peripheral CD19+ B cell count 6025 cells/bcL, ANC 61.0 x 10^9/L, hemoglobin 68 g/dL, platelet count 675 x 10^9/L, eGFR 630 mL/min/1.73m^2, total bilirubin 61.5 x ULN except Gilbert's Syndrome, AST and ALT 62.5 x ULN
- Concurrent corticosteroids allowed if dose is 6410 mg/day prednisone equivalent in 2 weeks before study
- Hydroxychloroquine up to 400 mg/day or chloroquine up to 250 mg/day allowed
You will not qualify if you...
- Active inflammatory disease other than rheumatoid arthritis within 12 months before or during screening except thyroiditis or secondary Sjogren's syndrome
- Significant unstable or uncontrolled acute or chronic disease other than rheumatoid arthritis posing undue risk or confounding results
- Prior treatment with cellular therapy such as CAR-T or gene therapy directed at any target
- Receipt of investigational therapy within 30 days or 5 drug-elimination half-lives before Day 1 and during study
- Anti-CD19 or anti-CD20 therapy within 3 months before Day 1
- Non-biologic DMARD within 14 days prior to Day 1
- Cyclophosphamide or biologic immunomodulating therapy within 2 months before Day 1
- Live or live-attenuated vaccines within 4 weeks before screening or during screening
- Active or latent tuberculosis unless previously treated and no current clinical signs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Cullinan Investigative Site
Erlangen, Germany
Actively Recruiting
2
Cullinan Investigative Site
Rome, Italy
Actively Recruiting
Research Team
A
Amy Gubits, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here