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

Last updated: June 26, 2025
Sponsor: Cullinan Therapeutics Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Lupus

Systemic Lupus Erythematosus

Cutaneous Lupus Erythematosus

Treatment

CLN-978

Clinical Study ID

NCT06613360
CLN-978-SL-101
  • Ages 18-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of SLE at least 24 weeks prior to Screening and meet 2019 EULAR / ACRClassification Criteria at screening.

  • Presence of one or more of the following autoantibodies documented during screening:positive anti-nuclear antibody (ANA) test (≥1:80); anti dsDNA above the upper limitof normal (ULN); anti-Sm above the ULN.

  • Active SLE disease, as demonstrated by a SLEDAI total score ≥8 at screening.

  • Inadequate response to at least 2 of the following treatments: oral corticosteroid,antimalarials, conventional immunosuppressants, or biologics. At least one of thefailed 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 CD19+ 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) ≥30mL/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

  • Serum albumin >2.8 g/dL

  • Part B only: For patients who were treated in Part A and did not experiencedose-limiting toxicity (DLT) or discontinue CLN-978 treatment due to AEs areeligible for retreatment at a higher dose or longer schedule in Part B if theyotherwise meet eligibility criteria and at least 90 days have passed since the lastdose of CLN-978.

Exclusion

Exclusion Criteria:

  • Active inflammatory disease other than SLE. Thyroiditis or secondary Sjogren'ssyndrome 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 or a biologic immunomodulating therapy during 2 months priorto 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 indeterminantInterferon Gamma Release Assay (IGRA), unless the patient has documented previouscompletion of TB treatment and no current clinical indication of TB.

  • Any condition for which, in the opinion of the Investigator and/or Sponsor, wouldnot be in the best interest of the patient to participate in the study or that couldprevent, limit, or confound any protocol-defined assessment.

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: CLN-978
Phase: 1
Study Start date:
January 21, 2025
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Cullinan Investigative Site

    Victoria Park,
    Australia

    Active - Recruiting

  • Arensia Research Clinic

    Tbilisi,
    Georgia

    Active - Recruiting

  • Arensia Research Clinic

    Chisinau,
    Moldova, Republic of

    Active - Recruiting

  • IMSP Republican Clinical Hospital "Timofei Mosneaga"

    Chisinau,
    Moldova, Republic of

    Active - Recruiting

  • Cullinan Investigative Site

    Avondale, Arizona 85392
    United States

    Active - Recruiting

  • Cullinan Investigative Site

    Tucson, Arizona 85704
    United States

    Active - Recruiting

  • Cullinan Investigative Site

    Orlando, Florida 32808
    United States

    Active - Recruiting

  • Omega Research Orlando, LLC

    Orlando, Florida 32808
    United States

    Active - Recruiting

  • Cullinan Investigative Site

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Cullinan Investigative Site

    New York, New York 10032
    United States

    Active - Recruiting

  • Cullinan Investigative Site

    Rochester, New York 14642
    United States

    Active - Recruiting

  • Cullinan Investigative Site

    Plano, Texas 75093
    United States

    Active - Recruiting

  • Cullinan Investigative Site

    Webster, Texas 77598
    United States

    Active - Recruiting

  • Tranquil Clinical Research

    Webster, Texas 77598
    United States

    Active - Recruiting

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