Actively Recruiting
A Phase I, Open-Label Study of CLN-978 in Patients With Treatment-Refractory Rheumatoid Arthritis (RA)
Led by Cullinan Therapeutics Inc. · Updated on 2026-05-15
37
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CLN-978, a CD19-directed T cell engager given by subcutaneous injection, in adults with rheumatoid arthritis (RA) that has not responded to other treatments. This Phase I, open-label study focuses on patients whose RA is driven by B cells and who have active disease despite trying at least two different targeted therapies. The trial aims to assess the safety and effects of CLN-978 in this treatment-refractory group. Participants will receive CLN-978 in two parts: an initial dose escalation phase to find appropriate dosing, followed by further evaluation at selected doses. The drug will be given on specified days, and patients will be monitored throughout the study. There is no placebo group, and the study is open-label, meaning both researchers and participants know the treatment given. During the study, participants will have laboratory tests to monitor blood counts, kidney and liver function, and immune response markers. Researchers will track adverse events for up to 48 weeks and measure drug levels and anti-drug antibodies for 12 weeks. Disease activity and other biomarkers related to treatment effects will also be assessed. The total study duration includes screening and treatment phases extending up to nearly one year.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Confirmed diagnosis of rheumatoid arthritis meeting the 2010 ACR/EULAR Classification Criteria for at least 12 weeks prior to screening
- Evidence of B-cell-driven disease by seropositivity or synovial biopsy
- 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 after failing conventional synthetic DMARDs
- Laboratory values within specified limits for lymphocyte count, CD19+ B cell count, neutrophil count, hemoglobin, platelet count, eGFR, bilirubin, AST, and ALT
- Use of corticosteroids up to 10 mg/day prednisone equivalent allowed if stable for 2 weeks prior to treatment
- Allowed stable doses of hydroxychloroquine or chloroquine
You will not qualify if you...
- Active inflammatory diseases other than rheumatoid arthritis within 12 months prior to screening, except thyroiditis or secondary Sjogren's syndrome
- Significant unstable or uncontrolled acute or chronic diseases not due to rheumatoid arthritis that may increase risk or affect study results
- Prior cellular therapy such as CAR-T or gene therapy targeting any antigen
- Receipt of investigational therapy within 30 days or 5 drug half-lives prior to Day 1 and during the study
- Anti-CD19 or anti-CD20 therapy within 3 months prior to Day 1
- Non-biologic DMARD use within 14 days prior to Day 1
- Cyclophosphamide or biologic immunomodulating therapy within 2 months prior to Day 1
- Live or live-attenuated vaccines within 4 weeks prior to screening or during screening
- Active or latent tuberculosis unless previously treated and no current clinical signs of TB
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 48 weeks
Participants receive specified doses of CLN-978 on scheduled days to treat rheumatoid arthritis.
Trial Site Locations
Total: 3 locations
1
University Hospital Erlangen
Erlangen, Germany, 91054
Actively Recruiting
2
University Hospital Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
3
Fondazione Policlinico Universitario A Gemelli
Rome, Italy, 00168
Actively Recruiting
Research Team
A
Amy Gubits, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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