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

June 4, 2026 updated by: Cullinan Therapeutics Inc.

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Parkville, Australia, 3050
        • Recruiting
        • Royal Melbourne Hospital
        • Contact:
      • Victoria Park, Australia, 6100
        • Recruiting
        • Osteoporosis Solutions
        • Contact:
  • Bulgaria
      • Sofia, Bulgaria, 1618
        • Recruiting
        • Multi profile Hospital for Active Treatment Sveta Sofia
        • Contact:
  • France
      • Nantes, France, 44093
      • Saint-Priest-en-Jarez, France, 42270
      • Toulouse, France, 31059
        • Recruiting
        • Centre Hospitalier Universitaire de Toulouse
        • Contact:
  • Georgia
      • Tbilisi, Georgia, 0112
  • Moldova
      • Chisinau, Moldova, 2025
        • Withdrawn
        • Timofei Moșneaga Republican Clinical Hospital
  • Romania
      • Bucharest, Romania, 011658
      • Cluj-Napoca, Romania, 400006
  • United States
    • Arizona
      • Avondale, Arizona, United States, 85392
      • Tucson, Arizona, United States, 85704
    • Florida
      • Orlando, Florida, United States, 32808
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
      • Rochester, New York, United States, 14642
    • Tennessee
      • Memphis, Tennessee, United States, 38103
    • Texas
      • Plano, Texas, United States, 75093
      • Webster, Texas, United States, 77598
    • Utah
      • Salt Lake City, Utah, United States, 84101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A Dose Escalation
Patients with SLE treated with CLN-978 in dose escalation cohorts
Drug: CLN-978
Specified dose on specified days
Experimental: Part B Further Dose Evaluation
Further evaluation of CLN-978 treatment of patients with SLE
Drug: CLN-978
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: 48 weeks
Incidence and severity of adverse events (AEs)/adverse events of special interest (AESIs)/serious adverse events (SAEs)
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics
Time Frame: 48 weeks
Serum concentrations of CLN-978
48 weeks
Immunogenicity
Time Frame: 48 weeks
Level of anti-drug antibodies
48 weeks
Pharmacodynamics-related biomarker
Time Frame: 48 weeks
Levels of total B lymphocytes in the peripheral blood
48 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)
Time Frame: 48 weeks
Change in hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score on a scale of 0 to12 with a higher score meaning worse outcome
48 weeks
Physicians Global Assessment
Time Frame: 48 weeks
Change in Physicians Global Assessment (PGA) score on a scale of 0 to 3 with a higher score indicating worse outcome
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cullinan Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-978-SL-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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