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New treatment option for Rheumatoid Arthritis (RA
Official title A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT06994143
What this study is testing
What is CLN-978?
CLN-978 is an investigational medicine, being studied as a potential treatment for rheumatoid arthritis (ra.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase I, open-label study of CLN-978 in patients with treatment-refractory rheumatoid arthritis.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Documented diagnosis of RA which fulfills the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification...
- Evidence of B-cell-driven disease at Screening or previous medical documentation, defined as either (i) seropositivity for RF and/or any AMPA and/or...
- Active RA disease, as demonstrated by a DAS28 - ESR ≥3.2 and at least one swollen joint at screening.
- Inadequate response to at least 2 targeted treatments with different mechanisms. These can include tsDMARD and/or bDMARD, after failing conventional...
- Local laboratory assessments must meet the following criteria:
You likely can't join if
- Active inflammatory disease other than RA within 12 months prior to screening or during screening that may interfere with the study assessments...
- Clinical evidence of any other significant unstable or uncontrolled acute or chronic disease not due to RA which, in the opinion of the Investigator...
- Prior treatment with the following:
- Cellular therapy (e.g., chimeric antigen receptor T-cell (CAR-T) or gene therapy product directed at any target.
- Receipt of an investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1 and during the study.
- Received any anti-CD19 or anti-CD20 therapy such as blinatumomab, obinutuzumab, rituximab, ocrelizumab, or ofatumumab within 3 months prior to Day 1.
See the full eligibility criteria
- Documented diagnosis of RA which fulfills the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria ≥12 weeks prior to screening.
- Evidence of B-cell-driven disease at Screening or previous medical documentation, defined as either (i) seropositivity for RF and/or any AMPA and/or (ii) a synovial biopsy showing B-cell infiltration
- Active RA disease, as demonstrated by a DAS28 - ESR ≥3.2 and at least one swollen joint at screening.
- Inadequate response to at least 2 targeted treatments with different mechanisms. These can include tsDMARD and/or bDMARD, after failing conventional synthetic DMARD (unless contraindicated).
- Local laboratory assessments must meet the following criteria:
- Absolute lymphocyte count (ALC) ≥0.5 x 10\^9/L
- Peripheral CD19+ B cell count ≥25 cells/μL
- Absolute neutrophil count (ANC) ≥1.0 x 10\^9/L
- Hemoglobin (Hgb) ≥8 g/dL
- Platelet count ≥75 x 10\^9/L
- Estimated glomerular filtration rate (eGFR) (based on the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) ≥30 mL/min/1.73m\^2
- Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN
- Concurrent corticosteroids is permitted if the dose is ≤10 mg/day prednisone equivalent in the 2 weeks prior to initiation of study treatment. Hydroxychloroquine ≤400 mg/d or chloroquine ≤ 250 mg/d is allowed.
- Active inflammatory disease other than RA within 12 months prior to screening or during screening that may interfere with the study assessments. Thyroiditis or secondary Sjogren's syndrome is allowed.
- Clinical evidence of any other significant unstable or uncontrolled acute or chronic disease not due to RA which, in the opinion of the Investigator could put the patient at undue risk or confound study results.
- Prior treatment with the following:
- Cellular therapy (e.g., chimeric antigen receptor T-cell (CAR-T) or gene therapy product directed at any target.
- Receipt of an investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1 and during the study.
- Received any anti-CD19 or anti-CD20 therapy such as blinatumomab, obinutuzumab, rituximab, ocrelizumab, or ofatumumab within 3 months prior to Day 1.
- Non-biologic DMARD within 14 days prior to Day 1.
- Cyclophosphamide or a biologic immunomodulating therapy within 2 months of Day 1.
- Live or live-attenuated vaccines within the 4 weeks prior to the Screening visit or during the Screening Period
- Active or latent tuberculosis (TB) evidenced by a positive or indeterminant Interferon Gamma Release Assay (IGRA), unless the patient has documented previous completion of TB treatment and no current clinical indication...
The study team makes the final eligibility decision.
Where it's taking place
- Erlangen, Germany
- Heidelberg, Germany
- Rome, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Erlangen, Germany; Heidelberg, Germany; Rome, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.