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New treatment option for SLE
Official title A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT06613360
What this study is testing
What is CLN-978?
CLN-978 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for sle.
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
- Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).
- 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 to 70
You may be able to join if
- Diagnosis of SLE at least 24 weeks prior to Screening and meet 2019 EULAR / ACR Classification Criteria at screening.
- Presence of one or more of the following autoantibodies documented during screening or in the previous 12 months before screening: positive...
- Active SLE disease, as demonstrated by a SLEDAI total score ≥6 at screening.
- Inadequate response to at least 2 of the following treatments: oral corticosteroid, antimalarials, conventional immunosuppressants, or biologics. At...
- If on corticosteroid and/or antimalarial, the dose must be stable prior to day 1.
You likely can't join if
- Active inflammatory disease other than SLE. Thyroiditis or secondary Sjogren's syndrome is allowed.
- Considered at high risk for thrombosis.
- Rapidly progressive glomerulonephritis, and/or urine protein/creatinine \>3 mg/mg (339 mg/mmol).
- Active severe neuropsychiatric/CNS manifestations of SLE.
- Evidence of hepatitis B, hepatitis C (HCV) infection, human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV)...
- History of splenectomy.
See the full eligibility criteria
- Diagnosis of SLE at least 24 weeks prior to Screening and meet 2019 EULAR / ACR Classification Criteria at screening.
- Presence of one or more of the following autoantibodies documented during screening or in the previous 12 months before screening: positive anti-nuclear antibody (ANA) test (≥1:80); anti dsDNA above the upper limit of...
- Active SLE disease, as demonstrated by a SLEDAI total score ≥6 at screening.
- Inadequate response to at least 2 of the following treatments: oral corticosteroid, antimalarials, conventional immunosuppressants, or biologics. At least one of the failed treatments should be an immunosuppressive or...
- If on corticosteroid and/or antimalarial, the dose must be stable prior to day 1.
- Laboratory parameters including the following:
- Absolute lymphocyte count (ALC) ≥0.5 x 109/L
- Peripheral B cell count ≥25 cells/µL
- Absolute neutrophil count (ANC) ≥1.0 x 109/L
- Hemoglobin ≥8 g/dL
- Platelet count ≥75 x 109/L.
- Estimated glomerular filtration rate (eGFR) (based on CKD-EPI formula) ≥30 mL/min/1.73m2
- Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN
- Part B only: For patients who were treated in Part A and did not experience dose-limiting toxicity (DLT) or discontinue CLN-978 treatment due to AEs are eligible for retreatment at a higher dose or longer schedule in...
- Active inflammatory disease other than SLE. Thyroiditis or secondary Sjogren's syndrome is allowed.
- Considered at high risk for thrombosis.
- Rapidly progressive glomerulonephritis, and/or urine protein/creatinine \>3 mg/mg (339 mg/mmol).
- Active severe neuropsychiatric/CNS manifestations of SLE.
- Evidence of hepatitis B, hepatitis C (HCV) infection, human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection.
- History of splenectomy.
- Prior treatment with the following:
- Cellular or gene therapy product directed at any target.
- Investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1.
- Any anti-CD19 or anti-CD20 therapy less than 3 months prior to Day 1.
- Non-biologic DMARD within 14 days prior to Day 1.
- Cyclophosphamide within 1 month or a biologic immunomodulating therapy during 2 months prior to Day 1.
- Live or attenuated vaccine within 28 days prior to screening or during screening.
- Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including SARS-CoV-2 infection, within 14 days before Day 1.
- 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...
- Any condition for which, in the opinion of the Investigator and/or Sponsor, would not be in the best interest of the patient to participate in the study or that could prevent, limit, or confound any protocol-defined...
The study team makes the final eligibility decision.
Where it's taking place
- Avondale, Arizona, United States
- Tucson, Arizona, United States
- Orlando, Florida, United States
- Iowa City, Iowa, United States
- New York, New York, United States
- Rochester, New York, United States
- Memphis, Tennessee, United States
- Plano, Texas, United States
- Webster, Texas, United States
- Salt Lake City, Utah, United States
- Parkville, Australia
- Victoria Park, Australia
- Sofia, Bulgaria
- Nantes, France
- Saint-Priest-en-Jarez, France
- Toulouse, France
- Tbilisi, Georgia
- Chisinau, Moldova
- Bucharest, Romania
- Cluj-Napoca, Romania
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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Avondale, Arizona, United States; Tucson, Arizona, United States; Orlando, Florida, United States; Iowa City, Iowa, United States; New York, New York, United States; Rochester, New York, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.