NCT07001839Not yet recruitingPhase 1
A Phase Ib Study of QLS4131 in Subjects With Systemic Lupus Erythematosus
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
Source: ClinicalTrials.gov · Last updated 3 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- First submitted
- 25 May 2025
- Start date
- Jun 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Diseases
- Lupus (SLE)
- NCT number
- NCT07001839
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 108
- From Jun 2025 to the primary completion date, Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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;
Other illness
- 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 a history of malignancy within 5 years prior to screening;
Other
- Participants with severe lupus nephritis;
- Pregnant or lactating women.
Who the study is looking for
- 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;
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.