Systemic Lupus ErythematosusPhase 1NCT07906145
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
A Phase 1 study testing QLS2416 Injection in people with Systemic Lupus Erythematosus and Rheumatoid Arthritis (RA), run by Shanghai Qilu Pharmaceutical Research and Development Center LTD.
Trial summary
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and efficacy of QLS2416 injection in participants with autoimmune diseases (AID). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA), Primary Sjögren's Syndrome (pSS)
- What is being tested?
- QLS2416 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2029
- 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
- Male or female participants aged 18 to 70 years (inclusive) at the time of ICF signing.
- Able to understand and voluntarily sign the written informed consent form (ICF).
- For SLE: Diagnosed with SLE per 2019 EULAR/ACR classification criteria; disease duration ≥ 24 weeks; SLEDAI-2K ≥ 4; inadequate response or intolerance to glucocorticoids combined with at least one immunosuppressant or biologic agent.
- For RA: Diagnosed with RA per 2010 ACR/EULAR classification criteria; disease duration ≥ 12 weeks; DAS28-CRP ≥ 3.2; TJC28 ≥ 4 and SJC28 ≥ 4; inadequate response to at least one csDMARD combined with at least one bDMARD/tsDMARD.
- For pSS: Diagnosed with pSS per 2016 ACR/EULAR classification criteria; disease duration ≥ 12 weeks and ≤ 10 years; clinESSDAI ≥ 5; positive ANA, anti-SSA/Ro, anti-SSB/La, or RF.
- For SSc: Diagnosed with diffuse cutaneous SSc per 2013 ACR/EULAR classification criteria; disease duration ≤ 7 years; mRSS > 10; PhGA ≥ 3.0.
- Women of childbearing potential must agree to use highly effective contraception throughout the study period and for 3 months after the last dose.
Who cannot join
- History of catastrophic antiphospholipid syndrome or saddle pulmonary embolism; new thromboembolic events within 1 year prior to screening; currently on anticoagulation therapy.
- Clinically significant cardiovascular or cerebrovascular disease, including decompensated heart failure (NYHA III/IV), uncontrolled severe hypertension, or severe arrhythmia.
- Severe respiratory disease, including severe pulmonary arterial hypertension, FVC% < 60%, or DLCOc% < 40%.
- History of malignancy within 5 years prior to screening (except adequately treated basal cell carcinoma, squamous cell carcinoma of skin, cervical carcinoma in situ, or papillary thyroid carcinoma).
- Active or chronic infections, including HIV infection, chronic HBV/HCV infection, latent or active tuberculosis (as applicable to study part).
- Known hypersensitivity to QLS2416 or any of its excipients; history of severe atopic disease or anaphylaxis.
Show all 10Show fewer
- Prior bone marrow transplantation; prior CAR-T, CAR-NK, or T-cell engager therapy.
- Laboratory abnormalities: hemoglobin < 80 g/L, WBC < 2.5×10^9/L, ANC < 1.0×10^9/L, platelets < 50×10^9/L, ALT/AST > 2×ULN, eGFR < 45 mL/min/1.73m², or IgG < 6 g/L.
- Pregnant or breastfeeding women.
- Major surgery within 2 months prior to screening; live vaccine within 4 weeks prior to screening.
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 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Efficacy of QLS2416 Injection in Participants With Autoimmune Diseases
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and efficacy of QLS2416 injection in participants with autoimmune diseases (AID).
The main questions it aims to answer are:
- What is the safety and tolerability profile of single and multiple ascending doses of QLS2416 injection?
This study consists of two parts. Participants will receive QLS2416 injection via subcutaneous administration in dose-escalation part and dose-expansion part. Safety assessments will be conducted throughout the study. Efficacy assessments will vary by disease indication.
Read the detailed description
This is a Phase 1, multicenter, open-label, dose-escalation and dose-expansion study of QLS2416 injection in participants with autoimmune diseases.
The study consists of two parts:
- Dose Escalation Part:
- Up to 42 participants with active SLE, RA, or pSS will be enrolled across up to 7 dose cohorts (0.025 mg to 6.0 mg).
- A Safety Monitoring Committee (SMC) will review safety, PK, pharmacodynamic (PD), and efficacy data before dose escalation.
- Dose Expansion Part:
- Approximately 24 participants with SLE and 10 participants with dcSSc will be enrolled
- Multiple dosing may be administered based on emerging safety, efficacy, and PK data.
QLS2416 is a novel biologic agent being developed for the treatment of B-cell-mediated autoimmune diseases. The study will characterize the safety, tolerability, PK, PD, immunogenicity, and preliminary efficacy of QLS2416 in participants with active autoimmune diseases who have had inadequate response or intolerance to standard therapies.
- Conditions
- Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA), Primary Sjögren's Syndrome (pSS), Systemic Sclerosis (SSc)
- Being tested
- QLS2416 Injection
- Keywords
- QLS2416, Autoimmune Diseases, Systemic Lupus Erythematosus, Rheumatoid Arthritis, Sjögren's Syndrome, Systemic Sclerosis
- Medical subject headings
- Lupus Erythematosus, Systemic, Arthritis, Rheumatoid, Scleroderma, Systemic, Autoimmune Diseases, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS2416 InjectionDrug
QLS2416 is a novel biologic agent administered via subcutaneous injection. Dose levels range from 0.025 mg to 6.0 mg.
| Study group | Role | What they receive |
|---|---|---|
| QLS2416 | Experimental | Dose Escalation Part: Participants with active SLE, RA, or pSS will receive single ascending subcutaneous doses of QLS2416 injection across 7 dose levels (0.025 mg to 6.0 mg).
Dose Expansion Part: Participants with active SLE or SSc will receive multiple dosing of QLS2416 injection at 3 dose levels within the 4-week treatment period. Receives: Drug: QLS2416 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of QLS2416 Injection
Incidence and severity of treatment-emergent adverse events.
Measured: Up to 24 weeks
Secondary outcomes (11)
Pharmacokinetic Profile of QLS2416
Peak Plasma Concertration(Cmax)
Measured: Up to 24 weeks
Pharmacokinetic Profile of QLS2416
Time to maximum plasma concentration(Tmax)
Measured: Up to 24 weeks
Pharmacokinetic Profile of QLS2416
Elimination half-life (t1/2)
Measured: Up to 24 weeks
Anti-Drug Antibody
Incidence of anti-QLS2416 antibodies (ADA)
Measured: Up to 24 weeks
SLE Responder Index (SRI) and Other SLE Disease Activity Measures
Percentage of participants achieving SRI (4)
Measured: Up to 24 weeks
SLE Responder Index (SRI) and Other SLE Disease Activity Measures
Percentage of participants achieving Definitions Of Remission In Systemic Lupus Erythematosus remission(DORIS remission)
Measured: Up to 24 weeks
SLE Responder Index (SRI) and Other SLE Disease Activity Measures
Percentage of participants achieving Lupus Low Disease Activity State(LLDAS)
Measured: Up to 24 weeks
RA Disease Activity Measures
Changes in Disease Activity Score in 28 Joints - C-reactive Protein (DAS28-CRP).
Measured: Up to 24 weeks
pSS Disease Activity Measures
Changes in Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (clinESSDAI).
Measured: Up to 24 weeks
SSc Disease Activity Measures
Changes in modified Rodnan skin score (mRSS).
Measured: Up to 52 weeks
SSc Disease Activity Measures
Changes in Combined Response Index for Systemic Sclerosis(CRISS).
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionDec 2029 (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.
- 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
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Qilu Pharmaceutical Research and Development Center LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906145
- Sponsor's protocol ID
- QLS2416-101
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 30 Oct 2026
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Efficacy of QLS2416 Injection in Participants With Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07906145
- Acronym / sponsor ID
- QLS2416-101
- Conditions
- Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA), Primary Sjögren's Syndrome (pSS), Systemic Sclerosis (SSc)
- Keywords
- QLS2416, Autoimmune Diseases, Systemic Lupus Erythematosus, Rheumatoid Arthritis, Sjögren's Syndrome, Systemic Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Shanghai Qilu Pharmaceutical Research and Development Center LTDIndustry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 30 Oct 2026 (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 clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and efficacy of QLS2416 injection in participants with autoimmune diseases (AID).
The main questions it aims to answer are:
- What is the safety and tolerability profile of single and multiple ascending doses of QLS2416 injection?
This study consists of two parts. Participants will receive QLS2416 injection via subcutaneous administration in dose-escalation part and dose-expansion part. Safety assessments will be conducted throughout the study. Efficacy assessments will vary by disease indication.
Detailed description
This is a Phase 1, multicenter, open-label, dose-escalation and dose-expansion study of QLS2416 injection in participants with autoimmune diseases.
The study consists of two parts:
- Dose Escalation Part:
- Up to 42 participants with active SLE, RA, or pSS will be enrolled across up to 7 dose cohorts (0.025 mg to 6.0 mg).
- A Safety Monitoring Committee (SMC) will review safety, PK, pharmacodynamic (PD), and efficacy data before dose escalation.
- Dose Expansion Part:
- Approximately 24 participants with SLE and 10 participants with dcSSc will be enrolled
- Multiple dosing may be administered based on emerging safety, efficacy, and PK data.
QLS2416 is a novel biologic agent being developed for the treatment of B-cell-mediated autoimmune diseases. The study will characterize the safety, tolerability, PK, PD, immunogenicity, and preliminary efficacy of QLS2416 in participants with active autoimmune diseases who have had inadequate response or intolerance to standard therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLS2416 | Experimental | Drug: QLS2416 InjectionDose Escalation Part: Participants with active SLE, RA, or pSS will receive single ascending subcutaneous doses of QLS2416 injection across 7 dose levels (0.025 mg to 6.0 mg). Dose Expansion Part: Participants with active SLE or SSc will receive multiple dosing of QLS2416 injection at 3 dose levels within the 4-week treatment period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female participants aged 18 to 70 years (inclusive) at the time of ICF signing.
- Able to understand and voluntarily sign the written informed consent form (ICF).
- For SLE: Diagnosed with SLE per 2019 EULAR/ACR classification criteria; disease duration ≥ 24 weeks; SLEDAI-2K ≥ 4; inadequate response or intolerance to glucocorticoids combined with at least one immunosuppressant or biologic agent.
- For RA: Diagnosed with RA per 2010 ACR/EULAR classification criteria; disease duration ≥ 12 weeks; DAS28-CRP ≥ 3.2; TJC28 ≥ 4 and SJC28 ≥ 4; inadequate response to at least one csDMARD combined with at least one bDMARD/tsDMARD.
- For pSS: Diagnosed with pSS per 2016 ACR/EULAR classification criteria; disease duration ≥ 12 weeks and ≤ 10 years; clinESSDAI ≥ 5; positive ANA, anti-SSA/Ro, anti-SSB/La, or RF.
Key exclusion criteria (10 listed)
- History of catastrophic antiphospholipid syndrome or saddle pulmonary embolism; new thromboembolic events within 1 year prior to screening; currently on anticoagulation therapy.
- Clinically significant cardiovascular or cerebrovascular disease, including decompensated heart failure (NYHA III/IV), uncontrolled severe hypertension, or severe arrhythmia.
- Severe respiratory disease, including severe pulmonary arterial hypertension, FVC% < 60%, or DLCOc% < 40%.
- History of malignancy within 5 years prior to screening (except adequately treated basal cell carcinoma, squamous cell carcinoma of skin, cervical carcinoma in situ, or papillary thyroid carcinoma).
- Active or chronic infections, including HIV infection, chronic HBV/HCV infection, latent or active tuberculosis (as applicable to study part).
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 |
|---|---|---|
| QLS2416 InjectionQLS2416 is a novel biologic agent administered via subcutaneous injection. Dose levels range from 0.025 mg to 6.0 mg. | Drug | QLS2416 |
Primary outcome
Safety and Tolerability of QLS2416 Injection
Time frame: Up to 24 weeks
Incidence and severity of treatment-emergent adverse events.
11 secondary outcomes
Pharmacokinetic Profile of QLS2416
Time frame: Up to 24 weeks
Pharmacokinetic Profile of QLS2416
Time frame: Up to 24 weeks
Pharmacokinetic Profile of QLS2416
Time frame: Up to 24 weeks
Anti-Drug Antibody
Time frame: Up to 24 weeks
SLE Responder Index (SRI) and Other SLE Disease Activity Measures
Time frame: Up to 24 weeks
SLE Responder Index (SRI) and Other SLE Disease Activity Measures
Time frame: Up to 24 weeks
SLE Responder Index (SRI) and Other SLE Disease Activity Measures
Time frame: Up to 24 weeks
RA Disease Activity Measures
Time frame: Up to 24 weeks
pSS Disease Activity Measures
Time frame: Up to 24 weeks
SSc Disease Activity Measures
Time frame: Up to 52 weeks
SSc Disease Activity Measures
Time frame: Up to 52 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 30 Oct 2026.
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
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 QLS2416 Injection in people with Systemic Lupus Erythematosus and Rheumatoid Arthritis (RA), run by Shanghai Qilu Pharmaceutical Research and Development Center 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 7 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 30 Oct 2026. 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 Rong Mu (010-82265699, Murongster@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of QLS2416 Injection (time frame: Up to 24 weeks). 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 30 Oct 2026.