Recruiting NCT06613360

A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus

Phase I Interventional SLE SLE (Systemic Lupus)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: CLN-978.
Who it may be relevant to: Registry conditions: SLE, SLE (Systemic Lupus). Basic parameters: 18 years — 70 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Bulgaria, France, Georgia +2
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

A Phase 1b, Open-label, Pilot Study of CLN-978 for the Treatment of Moderate to Severe Systemic Lupus Erythematosus (SLE)

Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).

Secondary outcome measures (3)

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 normal (ULN); anti-Sm above the ULN.
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 biologic standard-of care agent.
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 Part B if they otherwise meet eligibility criteria and at least 90 days have passed since the last dose of CLN-978.

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 of TB.
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 assessment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 10 centers

France · 3 centers

Australia · 2 centers

Romania · 2 centers

Bulgaria · 1 center

Georgia · 1 center

Moldova · 1 center

NCT: NCT06613360 · CLN-978-SL-101