CClinicalTrials.gg
Sign In
RecruitingNCT06857214Updated Jul 10, 2026

A Study of GNC-038 Tetra-specific Antibody Injection in Patients With Systemic Lupus Erythematosus

A Phase 1 interventional study of GNC-038 and Belimumab in Systemic Lupus Erythematosus, sponsored by Sichuan Baili Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by Sichuan Baili Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 4 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study is a randomized, controlled, phase I clinical study with safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics in patients with systemic lupus erythematosus.

Read the detailed description

This study is divided into Phase Ia and Phase Ib studies. The Phase Ia study adopts a single-arm design, while the Phase Ib study will be conducted on the basis of the Phase Ia study and features an open-label, randomized, active-controlled design, with belimumab as the control agent.

02

Conditions studied

  • Systemic Lupus Erythematosus
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's planned enrollment of 84 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Sichuan Baili Pharmaceutical Co., Ltd. is the lead sponsor of 140 studies on the registry; 100 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subjects can understand the informed consent form, voluntarily participate in and sign the informed consent form;
  2. No gender limit;
  3. Age: ≥18 years old and ≤75 years old;
  4. Life expectancy greater than 6 months;
  5. SLE was diagnosed according to the 2019 EULAR/ACR revised criteria;
  6. Patients with moderate to severe systemic lupus erythematosus, SLEDAI-2K score \&gt at screening; 7 points;
  7. A stable standard-of-care regimen was maintained for at least 30 days before the first dose;
  8. ANA ≥ 1:80 or anti-dsdna antibody higher than the upper limit of normal range (ULN) as determined by central laboratory at screening;
  9. The presence of CD19+ B cells in the peripheral blood of the patient;
  10. The organ function level before the first administration met the requirements;
  11. Female subjects of childbearing potential or male subjects with a fertile partner must use highly effective contraception from 7 days before the first dose until 24 weeks after the termination of treatment and should commit not to donate eggs (eggs, oocytes)/sperm for assisted reproduction for 1 year after the last study treatment. Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose;
  12. Participants were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.

Exclusion criteria

Exclusion Criteria:

  1. Severe lupus nephritis within 8 weeks before screening;
  2. She had uncontrolled lupus crisis within 8 weeks before screening and was not suitable for the study as assessed by the investigator;
  3. Active encephalopathy or psychosis within 6 months before screening;
  4. Primary diagnosis of different autoimmune or inflammatory diseases;
  5. B cell-depleting therapy within 6 months before initiation of GNC-038 treatment;
  6. Received CAR-T therapy within 6 months before GNC-038 treatment;
  7. Cytokine-targeting biologic agents used within 12 weeks before dose administration;
  8. Use of anti-tumor necrosis factor drugs within 8 weeks before administration;
  9. Use of any JAK inhibitor within 2 weeks before dosing;
  10. Receipt of any investigational drug within 28 days before dose or within 5 half-lives of the investigational drug;
  11. Major organ transplantation history or hematopoietic stem cell/bone marrow transplantation;
  12. Presence of: 1) active hepatitis B at screening; 2) hepatitis C or HIV infection; 3) syphilis infection;
  13. A history of any cardiovascular disease described in the protocol within 6 months before screening;
  14. Poorly controlled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);
  15. Prolonged QT interval at rest (QTcf > 450 msec in men or > 470 msec in women);
  16. A history of ≥ grade 2 bleeding within 30 days before screening or the need for long-term continuous anticoagulant therapy;
  17. Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of GNC-038;
  18. Women who are pregnant or breastfeeding;
  19. Have a history or evidence of suicidal thoughts within 6 months before signing ICF, which is considered by the researcher to be a significant risk of suicide;
  20. Diagnosed with malignant tumor within 5 years before signing ICF;
  21. Other situations of poor compliance, unwillingness or inability to comply with the study protocol as judged by the investigator;
  22. History of splenectomy;
  23. Investigators considered a history of alcohol or drug abuse in the 12 months before screening;
  24. Any active infection requiring systemic antibiotic treatment within 2 weeks before or during screening;
  25. A history of severe and/or disseminated viral infection;
  26. Active M. tuberculosis infection may be present.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    GNC-038

    Participants receive GNC-038 in the first cycle. Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

    Drug: GNC-038

  • Active comparator
    Belimumab

    The control group will be set up in phase Ib, participants will receive Belimumab.

    Drug: Belimumab

Interventions

  • DrugGNC-038

    Administration by intravenous infusion. Once a week (IV, QW), twice in total.

  • DrugBelimumab

    The first 3 doses are administered once every 2 weeks; starting from the 4th dose, once every 4 weeks.

06

What researchers measure

Primary outcomes

  1. Phase Ia: Dose limiting toxicity (DLT)

    DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration.

    Time frame: Up to approximately 28 days

  2. Phase Ia: Maximum tolerated dose (MTD)

    MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle.

    Time frame: Up to approximately 28 days

  3. Phase Ia: Treatment-Emergent Adverse Event (TEAE)

    TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of GNC-038. The type, frequency and severity of TEAE will be evaluated during the treatment of GNC-038.

    Time frame: Up to approximately 24 months

  4. Phase Ia: Cmax

    Maximum serum concentration (Cmax) of GNC-038 will be investigated.

    Time frame: Up to approximately 24 months

  5. Phase Ia: Tmax

    Time to maximum serum concentration (Tmax) of GNC-038 will be investigated.

    Time frame: Up to approximately 24 months

  6. Phase Ia: T1/2

    Half-life (T1/2) of GNC-038 will be investigated.

    Time frame: Up to approximately 24 months

  7. Phase Ia: AUC0-t

    AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.

    Time frame: Up to approximately 24 months

  8. Phase Ia: CL (Clearance)

    CL in the serum of GNC-038 per unit of time will be investigated.

    Time frame: Up to approximately 24 months

  9. Phase Ib: Recommended Phase II Dose (RP2D)

    The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of GNC-038.

    Time frame: Up to approximately 24 months

  10. Phase Ib: SRI-4 response rate

    SRI-4 response rate will be investigated.

    Time frame: Up to approximately 24 months

Secondary outcomes

  1. Anti-drug antibody (ADA)

    Frequency of anti-GNC-038 antibody (ADA) will be investigated.

    Time frame: Up to approximately 24 months

  2. Phase Ia: Receptor Occupancy (RO)

    Receptor Occupancy (RO) will be investigated.

    Time frame: Up to approximately 24 months

  3. Phase Ib: Change from baseline in SLEDAI-2K

    Change from baseline in SLEDAI-2K will be investigated.

    Time frame: Up to approximately 24 months

  4. Phase Ib: Changes in Quality of Life (SF-36)

    Changes in Quality of Life (SF-36) will be investigated.

    Time frame: Up to approximately 24 months

  5. Phase Ib: Proportion of subjects achieving Lupus Low Disease Activity Status (LLDAS)

    Proportion of subjects achieving Lupus Low Disease Activity Status (LLDAS) will be investigated.

    Time frame: Up to approximately 24 months

  6. Phase Ib: Proportion of subjects achieving disease remission (DORIS)

    Proportion of subjects achieving disease remission (DORIS) will be investigated.

    Time frame: Up to approximately 24 months

07

Study locations

1 of 1 sites recruiting
  • Renji Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai Municipality, China
    • Shuang Ye · Contact
    • Shuang Ye · Principal investigator
    • Qiong Fu · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06857214
Lead sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Mar 4, 2025
Start date
Jun 4, 2025
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jul 10, 2026

Study contacts

Sa Xiao, PHD
Contact
xiaosa@baili-pharm.com
15013238943

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lupus Erythematosus, Systemic→

Other studies from this sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Start the discussion