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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

A Phase 1, Open-label, Dose-escalation Study (ELEVATE-1) to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of a CD19/CD20 T-cell Engager in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD) (NCT07371468) is a Phase 1 interventional studying Systemic Lupus Erythematosus, sponsored by GlaxoSmithKline. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a 2-part study of GSK5926371 in participants with autoimmune rheumatic diseases (ARD). In part 1, participants will receive different doses of GSK5926371 to find a suitable priming dose. In part 2, participants will receive GSK5926371 at doses based on data from part 1. The study is aimed at testing if GSK5926371 is safe, well-tolerated, how the body processes the study drug, how it works in the body, and whether it triggers any immune responses.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Systemic Lupus Erythematosus, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 54 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Systemic Lupus Erythematosus subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Part 1 will enroll adult participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). - Part 2 will enroll adult participants with SLE, RA, idiopathic inflammatory myopathies (IIM) or Sjogren's disease (SjD). - Participants must be 18 to 70 years of age inclusive at the time of signing the willing to sign a consent form form. - Body mass index (BMI) between 18-35 kilograms per square meter (kg/m\^2) inclusive with a body weight of greater than or equal to (\>=) 45 kilograms (kg). - A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: - Is a participant of non-childbearing potential (PONCBP), OR - Is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\<) 1 percent (%), 28 days prior to and during the study intervention period and for at least 28 weeks after the first dose of GSK5926371. The investigator should evaluate potential for contraceptive method failure (e.g. noncompliance, recently initiated) in relationship to the first dose of study intervention. A POCBP must have a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. \- Signed and dated willing to sign a consent form form indicating that the participant is willing and able to comply with hospitalization, clinic visits and scheduled study assessments as detailed in the protocol. Who Should NOT Join This Trial: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Part 1 will enroll adult participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). * Part 2 will enroll adult participants with SLE, RA, idiopathic inflammatory myopathies (IIM) or Sjogren's disease (SjD). * Participants must be 18 to 70 years of age inclusive at the time of signing the informed consent form. * Body mass index (BMI) between 18-35 kilograms per square meter (kg/m\^2) inclusive with a body weight of greater than or equal to (\>=) 45 kilograms (kg). * A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: * Is a participant of non-childbearing potential (PONCBP), OR * Is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\<) 1 percent (%), 28 days prior to and during the study intervention period and for at least 28 weeks after the first dose of GSK5926371. The investigator should evaluate potential for contraceptive method failure (e.g. noncompliance, recently initiated) in relationship to the first dose of study intervention. A POCBP must have a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. \- Signed and dated informed consent form indicating that the participant is willing and able to comply with hospitalization, clinic visits and scheduled study assessments as detailed in the protocol. Exclusion Criteria: * Any acute, severe autoimmune disease-related flare before, or during the Screening Period (up to and including Day 1) that needs immediate treatment or is expected to require escalation of treatment to prohibited medications for the duration of the study. * Significant allergies to humanized monoclonal antibodies or significant sensitivity to any constituents of the study drug (including excipients). * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis). * Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to the autoimmune condition under study (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, or infectious diseases) and/or a planned surgical procedure, which, in the opinion of the investigator, could confound the results of the clinical study or put the participant at undue risk. * Have any other clinically significant abnormal laboratory value, that in the opinion of the investigator, is capable of significantly altering the absorption, metabolism, or elimination of the clinical study intervention; or constitutes a risk when taking the clinical study intervention or interferes with the interpretation of the clinical study data. * Participant has a diagnosis of primary or acquired immunodeficiency, except for selective IgA deficiency. * Have an acute or chronic infection including requiring management as follows: * An acute infection within 2 weeks of dosing on Day 1. * An active infection requiring current systemic antibiotic, antiviral or anti-fungal treatment with the exception of topical treatments for fungal nail infections. Prophylactic medications are permitted. * History of, or currently being treated for, a clinically significant recurrent or chronic infection (except for minor localized infections, for example tinea pedis). * Any opportunistic infections within past 3 years. Uncomplicated herpes zoster, localized herpes simplex virus, and oral candidiasis are not considered as opportunistic infections for this purpose. * Herpes zoster within 3 months before screening. * A serious infection requiring treatment with intravenous (IV)/intramuscular (IM) antibiotics and/or hospitalization if the last dose of antibiotics or the hospital discharge date was within 30 days of the first day of dosing (Day 1). * History of a serious infection associated with low serum immunoglobulin levels. * Evidence of active or latent tuberculosis (TB) as documented by medical history and examination (including chest X-rays \[CXR\], if available), and a positive (not indeterminate) TB test such as QuantiFERON-TB Gold Plus test. In cases where the QuantiFERON test is indeterminate, the participant may have the test repeated once, but if the test remains indeterminate further investigation may be required including CXR (posteroanterior \[PA\] and lateral) in order to exclude TB. Note: The QuantiFERON-TB Gold Plus test can only be used in countries where it is licensed, and the use of this test is dependent on previous treatment(s). This test may not be suitable if previous treatment(s) produced significant immunosuppression. * Confirmed progressive multifocal leukoencephalopathy (PML) within 12 months or has unexplained or deteriorating neurologic signs and symptoms. * History or positive test at Screening for human immunodeficiency virus (HIV). * History of clinically significant neurological or psychiatric disorder including history of epilepsy, dementia, increased risk of suicide as judged by the investigator or major depression deemed to interfere with study assessments, or a history of intracranial hemorrhage. * Solid or hematological malignancy or a history of malignancy (in the past 5 years) of except for basal cell or squamous cell in situ skin carcinomas, cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix that have been resected with no evidence of metastatic disease for 3 years. The investigator should also ensure that occult malignancy associated with the autoimmune condition under study has been adequately ruled out prior to screening (for example, malignancy-associated dermatomyositis). * History of hematological or solid organ transplant. * Live or live-attenuated vaccine(s) within 30 days before Screening or plans to receive such vaccines during the screening period or during the clinical study. * Current or prior treatment with any of the medications specified below during the relevant exclusion periods prior to Day 1. The following medications are prohibited from the periods before the study, until the last study visit: * IV or IM dose of corticosteroids within 5 weeks of Day 1. * Any T-cell engager (TCE) including blinatumomab, mosunetuzumab or other approved or investigational T cell engagers within 12 months of Day 1. * Chimeric antigen receptor (CAR)-T-cell treatment, at any time. * B-cell depleting agents, including but not limited to anti-CD20 (e.g. Rituximab, Obinutuzumab, Ocrelizumab), anti-CD38 (e.g. Daratumumab, TAK079, MOR202, isatuximab) within 4 months of Day 1. * Belimumab within 8 weeks of Day 1. * Anifrolumab within 8 weeks of Day 1. * Oral or IV cyclophosphamide within 12 weeks of Day 1. * Immune-Modulating Biologic agents, including anti-tumor necrosis factor (TNF) therapy (e.g., adalimumab and etanercept), abatacept, and interleukin (IL)-1 receptor antagonist \[anakinra\] or IL-6 receptor antagonist (tocilizumab) within 4 weeks of Day 1. Except infliximab, golimumab, and certolizumab within 8 weeks of Day 1. (NOTE: tocilizumab is permitted for cytokine release syndrome (CRS) Grade 3/4 management after dosing) * Small molecule inhibitors, including tyrosine kinase 2 inhibitor (TYK2i, Deucravacitinib); inhibitors of Janus kinases (JAKis, baricitinib, tofacitinib, upadacitinib, filgotinib); or Bruton tyrosine kinase inhibitors (ibrutinib, fenebrutinib) within 4 weeks of Day 1. * IV immunoglobulin within 8 weeks of Day 1. * Plasmapheresis within 8 weeks of Day 1. * Current enrolment or past participation in any other clinical study involving an investigational study treatment (including investigational vaccines) within 3 months or 5 half-lives of the investigational drug or twice the duration of pharmacological activity (whichever is longer) before Day 1. * Contra-indications to prophylactic medications for CRS (corticosteroid, ant histamines and antipyretics), or CRS rescue medication (tocilizumab or IV corticosteroids). * Current drug or alcohol dependence, or a history of drug or alcohol abuse or dependence within 12 months before Day 1. * Alanine transaminase (ALT) greater than (\>) 1.5 x upper limit of normal (ULN). * Total bilirubin \> 1.5 x ULN; Participants with Gilbert's syndrome can be included with total bilirubin \> 1.5 x ULN if direct bilirubin is \> 1.5 x ULN. * Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones). * Presence of hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis B virus (HBV) deoxyribonucleic acid (DNA) at screening or within 3 months prior to first dose of study intervention. * Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention. Note: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative hepatitis C ribonucleic acid (RNA) test is obtained. * Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention. Note: Test is optional and participants with negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing. * Corrected QT (QTc) interval \> 450 milliseconds (msec) or QTc interval \> 480 msec for participants with bundle branch block. Frederica's formula (QT interval corrected using Fridericia's formula \[QTcF\]) should be used to calculate the corrected QT interval. If a single electrocardiogram (ECG) at screening shows QTcF \> 450 msec (or \> 480 msec for participants with bundle branch block), a mean of triplicate measurements should be used to confirm that participant meets exclusion criterion.

Treatments Being Tested

BIOLOGICAL

GSK5926371

GSK5926371 will be administered.

Locations (3)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

GSK Investigational Site
Fukuoka, Japan
GSK Investigational Site
Hiroshima, Japan
GSK Investigational Site
Hokkaido, Japan

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07371468), the sponsor (GlaxoSmithKline), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07371468 clinical trial studying?

This is a 2-part study of GSK5926371 in participants with autoimmune rheumatic diseases (ARD). In part 1, participants will receive different doses of GSK5926371 to find a suitable priming dose. In part 2, participants will receive GSK5926371 at doses based on data from part 1. The study is aimed at testing if GSK5926371 is safe, well-tolerated, how the body processes the study drug, how it works in the body, and whether it triggers any immune responses. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07371468?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07371468?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07371468. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07371468. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.