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Systemic Lupus ErythematosusPhase 1NCT06857214

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

A Phase 1 study testing GNC-038 and Belimumab in people with Systemic Lupus Erythematosus, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
GNC-038 and Belimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteChina
Study dates
4 Jun 2025to Dec 2027
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects can understand the informed consent form, voluntarily participate in and sign the informed consent form;
  • No gender limit;
  • Age: ≥18 years old and ≤75 years old;
  • Life expectancy greater than 6 months;
  • SLE was diagnosed according to the 2019 EULAR/ACR revised criteria;
  • Patients with moderate to severe systemic lupus erythematosus, SLEDAI-2K score \&gt at screening; 7 points;
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  • A stable standard-of-care regimen was maintained for at least 30 days before the first dose;
  • ANA ≥ 1:80 or anti-dsdna antibody higher than the upper limit of normal range (ULN) as determined by central laboratory at screening;
  • The presence of CD19+ B cells in the peripheral blood of the patient;
  • The organ function level before the first administration met the requirements;
  • 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;
  • Participants were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sa Xiao, PHD contact

15013238943

xiaosa@baili-pharm.com

China1 site, 1 recruiting

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality

    Shuang Ye

    Shuang Ye

    Recruiting

Other trials in China

About this study

Official title: A Randomized Controlled Phase I Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GNC-038 Tetra-specific Antibody Injection in Systemic Lupus Erythematosus

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.

Being tested
GNC-038, Belimumab
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.

  • GNC-038Drug

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

  • BelimumabDrug

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

Study groups in NCT06857214
Study groupRoleWhat they receive
GNC-038ExperimentalParticipants 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.
Receives: Drug: GNC-038
BelimumabActive comparatorThe control group will be set up in phase Ib, participants will receive Belimumab.
Receives: Drug: Belimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: Up to approximately 24 months

  4. Phase Ia: Cmax

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

    Measured: Up to approximately 24 months

  5. Phase Ia: Tmax

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

    Measured: Up to approximately 24 months

  6. Phase Ia: T1/2

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

    Measured: 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.

    Measured: Up to approximately 24 months

  8. Phase Ia: CL (Clearance)

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

    Measured: 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.

    Measured: Up to approximately 24 months

  10. Phase Ib: SRI-4 response rate

    SRI-4 response rate will be investigated.

    Measured: Up to approximately 24 months

Secondary outcomes (6)

  1. Anti-drug antibody (ADA)

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

    Measured: Up to approximately 24 months

  2. Phase Ia: Receptor Occupancy (RO)

    Receptor Occupancy (RO) will be investigated.

    Measured: Up to approximately 24 months

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

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2025
  2. Study start4 Jun 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06857214
Sponsor's protocol ID
GNC-038-106
Status last verified
Jul 2026
First submitted
26 Feb 2025
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GNC-038 and Belimumab in people with Systemic Lupus Erythematosus, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

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 12 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Sa Xiao, PHD (15013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ia: Dose limiting toxicity (DLT) (time frame: Up to approximately 28 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06857214.

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 10 Jul 2026.

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