SLEPhase 1NCT06613360
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus
A Phase 1 study testing CLN-978 in people with SLE and SLE (Systemic Lupus), run by Cullinan Therapeutics Inc. at 24 sites in 9 countries.
Trial summary
Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- SLE, SLE (Systemic Lupus)
- What is being tested?
- CLN-978
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 24 sitesin 9 countries
- Study dates
- 21 Jan 2025to Dec 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
24 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
24 sites in 9 countries
United States12 sites, 11 recruiting
- Recruiting
AARA Clinical Research
Avondale, Arizona, 85392
Danaira Vasquez, 602-386-4971, danaira.vasquez@aaracr.com
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Kyle McBrearty, 617-355-2780, Kyle.McBrearty@childrens.harvard.edu
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Ashley Pieper, 319-356-0765, ashley-pieper@uiowa.edu
- Recruiting
Regional One Health
Memphis, Tennessee, 38103
Kimberly Barbee, 901-515-4520, kgbarbee@regionalonehealth.org
- Recruiting
NYU Grossman School of Medicine
New York, New York, 10016
Abraham Sinay-Smith, 646-501-7387, Abraham.Sinay-smith@nyulangone.org
- Withdrawn
Columbia University Medical Center
New York, New York, 10032
- Recruiting
Omega Research Group
Orlando, Florida, 32808
Audrey Treadway, 386-668-4202, atreadway@omegarcllc.com
- Recruiting
Stryde Research
Plano, Texas, 75093
Aarsheya Amin, 214-884-7721, aamin@stryderesearch.com
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Maria Allen, 585-275-7167, maria_allen@urmc.rochester.edu
- Recruiting
Intermountain Health
Salt Lake City, Utah, 84101
Carrie Rhodes, 801-408-4718, carrie.rhoades@imail.org
- Recruiting
AARA Clinical Research
Tucson, Arizona, 85704
Mikayla Kirby, 520-867-6906, Mikayla.Kirby@aaracr.com
- Recruiting
Tranquil Clinical Research
Webster, Texas, 77598
Viswakanth Makutam, 612-461-3159, sc@tranquilityresearch.com
France3 sites, 3 recruiting
- Recruiting
CHU de Nantes
Nantes, 44093
Antoine Néel, MD, 33 (0)2 40 08 33 55, antoine.neel@chu-nantes.fr
- Recruiting
University Hospital Saint Etienne
Saint-Priest-en-Jarez, 42270
Martin Killian, MD, 33 (0)4 77 82 91 79, martin.killian@chu-st-etienne.fr
- Recruiting
Centre Hospitalier Universitaire de Toulouse
Toulouse, 31059
Grégory Pugnet, MD, 33 (0)5 61 32 37 54, pugnet.g@chu-toulouse.fr
Australia2 sites, 2 recruiting
- Recruiting
Royal Melbourne Hospital
Parkville, 3050
Eleanor Chuan, 61 39 3426 464, Eleanor.Chuan@mh.org.au
- Recruiting
Osteoporosis Solutions
Victoria Park, 6100
Ravneet Kaur, 61 08 9472 1904, Ravneet@bdaus.com.au
Romania2 sites, 2 recruiting
- Recruiting
ARENSIA Exploratory Medicine S.R.L.
Bucharest, 011658
Andra Saulea, 40 787 423 325, andra.saulea@arensia-em.com
- Recruiting
Arensia Exploratory Medicine
Cluj-Napoca, 400006
Emanuela Beni, 40 711 912 839, emanuela.beni@arensia-em.com
Bulgaria1 site, 1 recruiting
- Recruiting
Multi profile Hospital for Active Treatment Sveta Sofia
Sofia, 1618
Bonka Toteva, 359 876 022 216, bonka.toteva@arensia-em.com
Georgia1 site, 1 recruiting
- Recruiting
ARENSIA Exploratory Medicine, LLC
Tbilisi, 0112
Ana Vardanashvili, 995 598 508 610, ana.vardanashvili@arensia-em.com
Germany1 site, 1 recruiting
- Recruiting
Klinikum der Ruprecht-Karls Universitaet Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Hanns-Martin Lorenz, 49 6221 56 38966, Hanns-Martin.Lorenz@med.uni-heidelberg.de
Moldova1 site
- Withdrawn
Timofei Moșneaga Republican Clinical Hospital
Chisinau, 2025
Spain1 site, 1 recruiting
- Recruiting
Hospital Quironsalud Infanta Luisa
Seville, 41010
Juan Miguel Sanchez Burson, 34 954330100, sitere3@gmail.com
About this study
Official title: 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).
- Conditions
- SLE, SLE (Systemic Lupus)
- Being tested
- CLN-978
- Keywords
- Systemic Lupus Erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLN-978Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A Dose Escalation | Experimental | Patients with SLE treated with CLN-978 in dose escalation cohorts Receives: Drug: CLN-978 |
| Part B Further Dose Evaluation | Experimental | Further evaluation of CLN-978 treatment of patients with SLE Receives: Drug: CLN-978 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Incidence and severity of adverse events (AEs)/adverse events of special interest (AESIs)/serious adverse events (SAEs)
Measured: 48 weeks
Secondary outcomes (3)
Pharmacokinetics
Serum concentrations of CLN-978
Measured: 48 weeks
Immunogenicity
Level of anti-drug antibodies
Measured: 48 weeks
Pharmacodynamics-related biomarker
Levels of total B lymphocytes in the peripheral blood
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start21 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cullinan Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613360
- Sponsor's protocol ID
- CLN-978-SL-101
- Status last verified
- Oct 2026
- First submitted
- 20 Sep 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No