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
- Are there results?
- Not yet: the study is under way
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
Moraima Avalos, 214-884-7558, mavalos@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
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-label, Pilot Study of CLN-978 for the Treatment of Moderate to Severe Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT06613360
- Acronym / sponsor ID
- CLN-978-SL-101
- Conditions
- SLE, SLE (Systemic Lupus)
- Keywords
- Systemic Lupus Erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cullinan Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A Dose Escalation | Experimental | Drug: CLN-978Patients with SLE treated with CLN-978 in dose escalation cohorts |
| Part B Further Dose Evaluation | Experimental | Drug: CLN-978Further evaluation of CLN-978 treatment of patients with SLE |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLN-978Specified dose on specified days | Drug | Part A Dose Escalation, Part B Further Dose Evaluation |
Primary outcome
Safety and tolerability
Time frame: 48 weeks
Incidence and severity of adverse events (AEs)/adverse events of special interest (AESIs)/serious adverse events (SAEs)
3 secondary outcomes
Pharmacokinetics
Time frame: 48 weeks
Immunogenicity
Time frame: 48 weeks
Pharmacodynamics-related biomarker
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
24 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, France, Australia, Romania, Bulgaria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meagan Sardinha (+1 617 410 4650, ClinOps@cullinantx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.