Can a new injection tame lupus when standard care fails?
NCT ID NCT07749430
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This early-phase trial is testing an investigational drug called ACG102, given by intravenous infusion, in people with refractory active systemic lupus erythematosus (SLE) — a form of lupus that has not responded well to standard treatments. The main goals are to check the drug's safety, tolerability, and how the body processes it, while also looking for early signs that it might reduce disease activity. About 13 adults with lupus will receive multiple infusions at different dose levels. The study is a first step to see if ACG102 is worth developing further as a potential treatment for hard-to-control lupus.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ACG102 injection
- What this could lead to
- If ACG102 proves safe and shows signs of easing lupus symptoms, it could become a new option for people whose disease does not respond to standard treatments.
- What could go wrong
- This is a very early, small study focused mainly on safety. It is too soon to know if ACG102 will work, and it may cause side effects or fail to improve lupus symptoms.
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
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 13 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Key Inclusion Criteria: 1. ≥18 years of age at time of informed consent. 2. Diagnosis of systemic lupus erythematosus (SLE) fulfilling the 2019 EULAR/ACR classification criteria. 3. Refractory active disease defined as inadequate response to, or relapse following, standard of care (SoC) therapy. 4. Patients on a stable dose of SoC for at least 4 weeks prior to enrollment. 5. Sufficient organ function as defined by the protocol. Key Exclusion Criteria: 1. Active severe infection, including tuberculosis. 2. Severe hypogammaglobulinemia or IgA deficiency. 3. Active hepatitis or history of severe liver disease. 4. Severe cardiovascular diseases. 5. History of cancer within the past 5 years (with exceptions per protocol). 6. Receipt of B-cell-targeted therapies or other biologic therapies within the defined washout window prior to enrollment. 7. History of organ transplantation, bone marrow transplantation, or hematopoietic stem cell transplantation. 8. Known allergy to any active or inactive component of the study drug.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.