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Could a single injection tame lupus and Sjögren's?

NCT ID NCT07751315

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This early-stage trial is evaluating an investigational drug called QLS2404, given as an injection, to see if it is safe and tolerable. The study first tests single doses in healthy volunteers, then moves to multiple doses in people with systemic lupus erythematosus or primary Sjögren's syndrome. Researchers will also look at how the drug moves through the body and whether it shows any signs of helping these autoimmune conditions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
QLS2404 injection
What this could lead to
If successful, this could point toward a new treatment option for autoimmune diseases like lupus and Sjögren's syndrome, potentially helping to control symptoms and reduce disease activity.
What could go wrong
This is an early-phase trial, so the main focus is safety, not effectiveness. The drug may not work as hoped, and side effects are possible. Results from this small study will need confirmation in larger trials.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

Inclusion Criteria: * Ia * Participants who understand and comply with the study procedures and methods, voluntarily participate in this trial, provide written informed consent, and are able to complete the study in accordance with the protocol requirements. * Male or female participants aged ≥18 and ≤45 years on the date of signing the informed consent form. * Body mass index (BMI) at screening ≥19 kg/m² and ≤26 kg/m², with body weight ≥45 kg. * Participants assessed by the investigator to be in good health based on medical history, physical examination, vital signs, and laboratory test results during the screening period. * Ib * Participants who voluntarily sign the informed consent form before the initiation of any study-related procedures, are able to communicate effectively with the investigator, understand and are willing to strictly comply with the requirements of this clinical study protocol, and complete the study. * Male or female participants aged ≥18 and ≤65 years at the time of signing the informed consent form. * Body mass index (BMI) at screening ≥18 kg/m² and ≤35 kg/m². * Participants with systemic lupus erythematosus must meet the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE and be diagnosed with systemic lupus erythematosus; the diagnosis must have been established at least 6 months prior to signing the informed consent form. * Participants with primary Sjögren's syndrome must meet the 2016 ACR/EULAR classification criteria for primary Sjögren's syndrome and be diagnosed with primary Sjögren's syndrome; the diagnosis must have been established at least * months prior to signing the informed consent form. Exclusion Criteria: * Ia * QTcF interval corrected by electrocardiogram (ECG) ≥450 ms at screening; and any other ECG abnormalities that, in the investigator's opinion, may pose an unacceptable risk to the participant. * Participants with a history of, or current, chronic or serious diseases of the musculoskeletal, neuropsychiatric, endocrine, circulatory, respiratory, digestive, urinary, reproductive, or other systems, who are considered by the investigator to be unsuitable for participation in the clinical trial. * Participants who have lost more than 400 mL of blood due to blood donation or other reasons within 3 months prior to screening. * Participants who are considered by the investigator to be unsuitable for participation in the clinical trial or unable to complete this study for other reasons. * Ib * Any disease or condition that, in the investigator's opinion, may interfere with the evaluation of study drug efficacy, participant safety assessment, or interpretation of study results. * Participants who have participated in any cell therapy, gene therapy clinical trial, or medical device clinical trial within 3 months prior to screening. * Participants who have received Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to screening. * Participants who have received any live attenuated vaccine within 1 month prior to screening or who require live attenuated vaccination during study participation. * Participants who are breastfeeding or have a positive serum human chorionic gonadotropin (hCG) test during the screening period.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041, China

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Other studies related to the condition(s) this trial covers.