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Using CLN-978 to treat patients with systemic lupus erythematosus

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

Phase 1 Interventional Cullinan Therapeutics Inc. · NCT06613360

This study is testing a new treatment called CLN-978 to see if it can help people with moderate to severe lupus who haven't responded well to other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment24 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorCullinan Therapeutics Inc. Industry-sponsored
Drugs / interventionsCyclophosphamide
Locations15 sites (Avondale, Arizona and 14 other locations)
Trial IDNCT06613360 on ClinicalTrials.gov

What this trial studies

This is a Phase 1b, open-label study evaluating the safety and efficacy of CLN-978, a CD19-directed T cell engager, administered subcutaneously to patients with moderate to severe systemic lupus erythematosus (SLE). The study aims to enroll participants who have been diagnosed with SLE and have shown inadequate response to standard treatments. Participants will be monitored for their disease activity and response to the treatment over the course of the study. The goal is to assess the potential of CLN-978 to improve symptoms and disease management in this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults diagnosed with moderate to severe systemic lupus erythematosus who have not responded to at least two standard treatments.

Not a fit: Patients with mild SLE or those who have not previously received standard treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with systemic lupus erythematosus who have not responded adequately to existing therapies.

How similar studies have performed: While this approach is novel in the context of SLE, similar CD19-directed therapies have shown promise in other autoimmune conditions.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion 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 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 Criteria:

* 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.

Where this trial is running

Avondale, Arizona and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions SLESystemic Lupus Erythematosus
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.