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A Study of CLN-978 for Systemic Lupus Erythematosus

This study is testing a drug called CLN-978, which is given under the skin, for people with moderate to severe Systemic Lupus Erythematosus (SLE). SLE is an autoimmune disease where the body's immune system attacks its own tissues. Researchers want to see how safe CLN-978 is and how well people tolerate it over 48 weeks. You might be able to join if you are between 18 and 70 years old, have been diagnosed with SLE for at least 24 weeks, and have specific autoantibodies (immune proteins) like ANA, anti-dsDNA, or anti-Sm. The study is currently unclear about its recruitment status and plans to enroll 24 participants.

Study design
This is a Phase 1b, open-label study, meaning both you and the study team will know you are receiving CLN-978. It plans to include 24 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure safety and tolerability for 48 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06613360

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

Recruiting
PHASE1Ages 18–70InterventionalTreatment
Cullinan Therapeutics Inc.
~24 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:CLN-978

At a glance

Recruiting sites
19 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability
Measured over 48 weeks

Conditions

SLE
SLE (Systemic Lupus)

Explore related trials

Systemic Lupus ErythematosusAnti-ds DNA AntibodyAntinuclear Antibodyanti-SmCD19 Gene

Where it's being run

20 sites across 13 states
France3
Arizona2
New York2
Texas2
Australia2
Romania2
Florida1
Iowa1

Who to contact

Meagan Sardinha
[email protected]
+1 617 410 4650
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

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

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.

What this trial measures

  • Safety and tolerability48 weeks

    Incidence and severity of adverse events (AEs)/adverse events of special interest (AESIs)/serious adverse events (SAEs)