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New lupus drug CLN-978 enters early human testing

NCT ID NCT06613360

Disease control Sponsor: Cullinan Therapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new drug called CLN-978 in 24 people with moderate to severe lupus. The main goal is to see if the drug is safe and tolerable. Researchers will also measure how the drug moves through the body and how it affects immune cells. This is a first step to see if CLN-978 might help control lupus symptoms.

Why investors are watching

Cullinan Therapeutics is testing CLN-978, an experimental drug given by injection, in 24 people with moderate to severe lupus. This early-stage trial will show whether the drug is safe and whether it can control the disease, which matters because the company is small and this is one of its main pipeline programs. A clear signal of effectiveness could validate the drug's approach and support further development.

If it works: If the trial shows CLN-978 reduces lupus activity with an acceptable safety profile, the company could advance the drug to later-stage studies. That progress could strengthen its pipeline and attract partnership interest.

If it fails: Early-stage trials often fail to show enough benefit or reveal safety problems, and this one has only 24 participants, so results may be inconclusive. A poor outcome or delay could set back the program and hurt the company's prospects.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SLE SLE (systemic lupus)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AARA Clinical Research

    RECRUITING

    Avondale, Arizona, 85392, United States

  • AARA Clinical Research

    RECRUITING

    Tucson, Arizona, 85704, United States

  • ARENSIA Exploratory Medicine S.R.L.

    RECRUITING

    Bucharest, 011658, Romania

  • ARENSIA Exploratory Medicine, LLC

    RECRUITING

    Tbilisi, 0112, Georgia

  • Arensia Exploratory Medicine

    RECRUITING

    Cluj-Napoca, 400006, Romania

  • CHU de Nantes

    RECRUITING

    Nantes, 44093, France

  • Centre Hospitalier Universitaire de Toulouse

    RECRUITING

    Toulouse, 31059, France

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Intermountain Health

    RECRUITING

    Salt Lake City, Utah, 84101, United States

  • Multi profile Hospital for Active Treatment Sveta Sofia

    RECRUITING

    Sofia, 1618, Bulgaria

  • Omega Research Group

    RECRUITING

    Orlando, Florida, 32808, United States

  • Osteoporosis Solutions

    RECRUITING

    Victoria Park, 6100, Australia

  • Regional One Health

    RECRUITING

    Memphis, Tennessee, 38103, United States

  • Royal Melbourne Hospital

    RECRUITING

    Parkville, 3050, Australia

  • Stryde Research

    RECRUITING

    Plano, Texas, 75093, United States

  • Timofei Moșneaga Republican Clinical Hospital

    WITHDRAWN

    Chisinau, 2025, Moldova

  • Tranquil Clinical Research

    RECRUITING

    Webster, Texas, 77598, United States

  • University Hospital Saint Etienne

    RECRUITING

    Saint-Priest-en-Jarez, 42270, France

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14642, United States

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