NCT07906145Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Efficacy of QLS2416 Injection in Participants With Autoimmune Diseases
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 76 (estimated)
- First submitted
- 23 Oct 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- Shanghai Qilu Pharmaceutical Research and Development Center LTD
- NCT number
- NCT07906145
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 76
- From 1 Dec 2026 to the primary completion date, 30 Jun 2029
- 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
- History of catastrophic antiphospholipid syndrome or saddle pulmonary embolism; new thromboembolic events within 1 year prior to screening; currently on anticoagulation therapy.
- Prior bone marrow transplantation; prior CAR-T, CAR-NK, or T-cell engager therapy.
- Major surgery within 2 months prior to screening; live vaccine within 4 weeks prior to screening.
Other illness
- 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.
Lab values
- 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.
Other
- Pregnant or breastfeeding women.
Who the study is looking for
- 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.
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.