Systemic Lupus ErythematosusPhase 1NCT07001839
A Phase Ib Study of QLS4131 in Subjects With Systemic Lupus Erythematosus
A Phase 1 study testing QLS4131 for Injection. in people with Systemic Lupus Erythematosus, run by Qilu Pharmaceutical Co., Ltd..
Trial summary
The goal of this open label, dose escalation phase 1b clinical trial is to investigate the safety, tolerability, pharmacokinetic, pharmacodynamics, immunogenicity and preliminary clinical efficacy of QLS4131 in subjects with systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- QLS4131 for Injection.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Dec 2026
- 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
- Aged 18 to 70 (inclusive);
- Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (ACR) Classification Criteria at least 12 weeks or more prior to screening;
- Participants with positive antinuclear antibody (ANA) (≥ 1:80), or positive anti-dsDNA antibody and/or positive anti-Sm antibody at screening;
- Active SLE disease at screening, as demonstrated by a SLEDAI-2K >= 8 at screening, or SLEDAI-2K >= 6 at the presence of low complement and/or positive anti-dsDNA antibodies;
- Current receipt of one or more of the following classes of standard therapies for the treatment of SLE at stable doses: oral corticosteroids, antimalarial agents, and conventional immunosuppressants:
- For participants receiving an oral corticosteroid, treatment with ≤40 mg/day prednisone or equivalent, at a dose that has been stable for at least 4 weeks prior to first dose;
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- For participants receiving an antimalarial, the medication(s) must have been at a stable dose ≥ 4 weeks prior to the first dose;
- For participants receiving immunosuppressants, treatment with a single immunosuppressant at a stable dose for ≥ 4 weeks prior to the first dose: conventional immunosuppressants include azathioprine, mycophenolate mofetil, mycophenolic acid, and methotrexate (oral, subcutaneous or intravenous routes).
- Participants who understand and abide by the study procedures, voluntarily participate in this study, and sign the Informed Consent Form in person.
Who cannot join
- Participants with known intolerance or allergy to the investigational product or drugs that may be used in the study (e.g., Tocilizumab) and any components;
- Participants with active severe active or unstable lupus-associated neuropsychiatric disease;
- Participants with other autoimmune diseases that may affect the efficacy evaluation;
- Participants with poorly controlled hypertension and diabetes;
- Participants with severe lupus nephritis;
- Participants with a history of malignancy within 5 years prior to screening;
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- Participants with a previous history of vital organ transplantation;
- Participants who have had opportunistic infections within 12 weeks prior to the first dose;
- Receipt of any CAR-T, CAR-NK or other gene therapy;
- Pregnant or lactating women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Effectiveness of QLS4131 for Injection in Patients With Systemic Lupus Erythematosus
The goal of this open label, dose escalation phase 1b clinical trial is to investigate the safety, tolerability, pharmacokinetic, pharmacodynamics, immunogenicity and preliminary clinical efficacy of QLS4131 in subjects with systemic lupus erythematosus (SLE). The main questions it aims to answer are:
- The safety, tolerability and maximum tolerated dose (MTD) of QLS4131 for Injection in participants with SLE.
- The recommended Phase 2 dose (RP2D) of QLS4131 for Injection in participants with SLE.
Participants will be administered different target dose of QLS4131 for Injection only once. A step-up dosing approach will be implemented at high dose level as determined by the safety monitoring committee.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- QLS4131 for Injection.
- Keywords
- QLS4131; Systemic lupus erythematosus; T cell engager
- 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.
QLS4131 for Injection.Drug
Eligible participants will be assigned to 1 of the 9 dose groups ranging from 0.06 μg/kg to 600 μg/kg.
| Study group | Role | What they receive |
|---|---|---|
| QLS4131 | Experimental | Target dose of each cohort will be administered only once Receives: Drug: QLS4131 for Injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of treatment emergence adverse events.
Measured: Up to 24 weeks]
Recommended Phase 2 Dose
Measured: Approximately 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001839
- Sponsor's protocol ID
- QLS4131-201
- Status last verified
- May 2025
- First submitted
- 25 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Effectiveness of QLS4131 for Injection in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07001839
- Acronym / sponsor ID
- QLS4131-201
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- QLS4131; Systemic lupus erythematosus; T cell engager
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Jun 2025 (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.
The goal of this open label, dose escalation phase 1b clinical trial is to investigate the safety, tolerability, pharmacokinetic, pharmacodynamics, immunogenicity and preliminary clinical efficacy of QLS4131 in subjects with systemic lupus erythematosus (SLE). The main questions it aims to answer are:
- The safety, tolerability and maximum tolerated dose (MTD) of QLS4131 for Injection in participants with SLE.
- The recommended Phase 2 dose (RP2D) of QLS4131 for Injection in participants with SLE.
Participants will be administered different target dose of QLS4131 for Injection only once. A step-up dosing approach will be implemented at high dose level as determined by the safety monitoring committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLS4131 | Experimental | Drug: QLS4131 for Injection.Target dose of each cohort will be administered only once |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 to 70 (inclusive);
- Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (ACR) Classification Criteria at least 12 weeks or more prior to screening;
- Participants with positive antinuclear antibody (ANA) (≥ 1:80), or positive anti-dsDNA antibody and/or positive anti-Sm antibody at screening;
- Active SLE disease at screening, as demonstrated by a SLEDAI-2K >= 8 at screening, or SLEDAI-2K >= 6 at the presence of low complement and/or positive anti-dsDNA antibodies;
- Current receipt of one or more of the following classes of standard therapies for the treatment of SLE at stable doses: oral corticosteroids, antimalarial agents, and conventional immunosuppressants:
Key exclusion criteria (10 listed)
- Participants with known intolerance or allergy to the investigational product or drugs that may be used in the study (e.g., Tocilizumab) and any components;
- Participants with active severe active or unstable lupus-associated neuropsychiatric disease;
- Participants with other autoimmune diseases that may affect the efficacy evaluation;
- Participants with poorly controlled hypertension and diabetes;
- Participants with severe lupus nephritis;
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 |
|---|---|---|
| QLS4131 for Injection.Eligible participants will be assigned to 1 of the 9 dose groups ranging from 0.06 μg/kg to 600 μg/kg. | Drug | QLS4131 |
Primary outcome
incidence of treatment emergence adverse events.
Time frame: Up to 24 weeks]
Recommended Phase 2 Dose
Time frame: Approximately 24 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 3 Jun 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QLS4131 for Injection. in people with Systemic Lupus Erythematosus, run by Qilu Pharmaceutical Co., Ltd..
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 9 inclusion and 10 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: opening soon, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Dandan Guo, PM (13668889421, dandan1.guo@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of treatment emergence adverse events. (time frame: Up to 24 weeks]). The study lists 2 primary outcomes in all. 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 3 Jun 2025.