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)

Plain English Summary

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD) is a Phase 1 clinical trial sponsored by GlaxoSmithKline studying Systemic Lupus Erythematosus. This study is testing a new drug called GSK5926371 in adults with certain autoimmune diseases. It is for people with conditions like Lupus or Rheumatoid Arthritis who meet specific health and age requirements. Participation involves receiving the study drug at different doses, with regular check-ups and tests to monitor safety and how the body responds. Alternative treatments for these conditions include other medications that suppress the immune system or target specific parts of the immune response. The trial aims to enroll 54 participants.

Official Summary

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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18-70 with Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA) can join Part 1. Adults with SLE, RA, Idiopathic Inflammatory Myopathies (IIM), or Sjogren's Disease (SjD) can join Part 2. Participants must have a Body Mass Index (BMI) between 18-35 and weigh at least 45 kg. Women who are pregnant or breastfeeding cannot participate, and women of childbearing potential must use highly effective contraception. This trial is studying Systemic Lupus Erythematosus, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how many participants experience side effects, both expected and serious, which helps doctors understand how safe the new drug is. The specific primary outcome measures are: Part 1 and Part 2: Number of Participants with Adverse Events (AEs) and Serious AEs (SAEs) (Up to 196 days). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial is important because it explores a new approach to treating autoimmune rheumatic diseases by targeting specific cells involved in the disease process, potentially filling a gap for patients This research targets Systemic Lupus Erythematosus, where improved treatment options are needed.

Investor Insight

This Phase 1 trial is an early step for GSK5926371, a novel T-cell engager, in the large and competitive autoimmune disease market, with a focus on establishing safety and tolerability before further Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the potential benefits and risks of GSK5926371, and how it compares to your current treatment. Be prepared for regular clinic visits, blood draws, and other tests to monitor your health and the drug's effects. Understand that you may receive different doses of the study drug as researchers determine the best dosage. This trial is currently recruiting participants. The trial is being conducted at 3 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SEQUENTIAL
• Masking: NONE
• Enrollment: 54 participants

Interventions

• BIOLOGICAL: GSK5926371 — GSK5926371 will be administered.

Primary Outcomes

• Part 1 and Part 2: Number of Participants with Adverse Events (AEs) and Serious AEs (SAEs) (Up to 196 days)

Secondary Outcomes

• Part 1: Maximum Observed Plasma Concentration (Cmax) After GSK5926371 Dosing (Up to 43 days)
• Part 2: Cmax After GSK5926371 Dosing (Up to 113 days)
• Part 1 and Part 2: Number of Participants with Anti-drug Antibodies (ADAs) Against GSK5926371 (Up to 196 days)
• Part 1 and Part 2: Titers of ADAs Against GSK5926371 (Up to 196 days)
• Part 1: Absolute B-cell and T-cell Counts in Blood (Up to 57 days)

Full Eligibility Criteria

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 

Trial Locations

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

Frequently Asked Questions

Related Conditions

• Systemic Lupus Erythematosus
• Rheumatoid Arthritis
• Idiopathic Inflammatory Myopathies
• Sjogren's Disease
• Autoimmune Diseases
• B-cell Lymphoma (as a related therapeutic area for CD19/CD20 targeting)
• Immunology
• Rheumatology
• Inflammatory Diseases
• Oncology (due to targeted cell therapy approaches)

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