Tests CLN-978 in adults with moderate to severe systemic lupus
Tests CLN-978, an injected drug, in adults with moderate to severe lupus.
Plain-language title generated from the registry record
Registry title: A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus
Key facts
- Where
- Heidelberg, GermanySee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderate to severe systemic lupus erythematosus (SLE) that is active and has not responded well to earlier treatments. It tests CLN-978, given under the skin.
- Age
- 18 to 70 years
- Sex
- All sexes can join.
- Disease stage
- SLE diagnosed at least 24 weeks before screening. The disease must be active (SLEDAI total score ≥6 at screening).
- Earlier treatment
- Inadequate response to at least 2 of these: oral corticosteroid, antimalarials, conventional immunosuppressants, or biologics. At least one must be an immunosuppressive or biologic standard-of-care agent. Corticosteroid or antimalarial doses must be stable before day 1. Cannot have had any anti-CD19 or anti-CD20 therapy less than 3 months before day 1, or any cellular or gene therapy.
- Biomarker or test result
- At least one autoantibody result in screening or in the previous 12 months: positive ANA (≥1:80), or anti-dsDNA or anti-Sm above the upper limit of normal. Blood counts, kidney and liver tests must be within set limits.
Main reasons for not taking part
- Active inflammatory disease other than SLE
- Evidence of hepatitis B, hepatitis C, HIV, EBV or CMV infection
- Rapidly progressive glomerulonephritis or urine protein/creatinine >3 mg/mg
- Active or latent tuberculosis, or other active infection within 14 days before day 1
- History of splenectomy
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06613360, who can take part
Where in Germany
- Universitaetsklinikum Heidelberg AöRHeidelberg, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cullinan Therapeutics Inc.
- Trial code
- NCT06613360EU 2024-518780-36-00
- Record updated
- 26 October 2026
- Original description
Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).Read full original descriptionShow less
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).
Inclusion: 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.
Exclusion: 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; Active inflammatory disease other than SLE. Thyroiditis or secondary Sjogren's syndrome is allowed; Considered at high risk for thrombosis; Evidence of hepatitis B, hepatitis C (HCV) infection, human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection; History of splenectomy; 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; Rapidly progressive glomerulonephritis, and/or urine protein/creatinine >3 mg/mg (339 mg/mmol); Active severe neuropsychiatric/CNS manifestations of SLE.