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Systemic Lupus Erythematosus (SLE)Phase 1NCT06945068

An Open-label Study of GB261 in Refractory Seropositive Systemic Lupus Erythematosus

A Phase 1 study testing GB261 in people with Systemic Lupus Erythematosus (SLE), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of the study is to evaluate the safety and efficacy of CD20xCD3 T-cell engager (GB261) in patients with refractory seropositive 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 (SLE)
What is being tested?
GB261
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteChina
Study dates
Jun 2025to 30 Nov 2026
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

  • 18 to 75 years old at the time of signing the informed consent form (ICF)
  • Diagnosis of SLE according to the 2019 American College of Rheumatology (ACR), European Alliance of Associations for Rheumatology (EULAR) classification criteria
  • 3. Positive for 2 out of 3 antibodies at Screening: a. Anti-dsDNA; b. Anti-Smith antibodies; c. Antinuclear antibody (ANA) titer ≥1:80
  • Active SLE disease
  • Inadequate response
  • Current and stable use of some medication up to Day 1
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  • Current and stable use of some medication must be discontinued ≥1 week prior to Day 1
  • Additional Inclusion Criteria for SLE with Active LN
  • SLE patients with active LN are eligible to be included in the study only if all of the following additional criteria apply:
  • Active, biopsy-proven, proliferative LN Class III or IV according to the 2018 International Society of Nephrology/Renal Pathology Society criteria
  • Inadequate response
  • Stable angiotensin-converting enzyme inhibitors/angiotensin receptor blockers for at least 4 weeks prior to Screening

Who cannot join

  • Inadequate clinical laboratory parameters at Screening:
  • Patients will be excluded if they are known to have active infection
  • Receipt of or inability to discontinue any excluded therapies
  • Receipt of live vaccine within 4 weeks prior to Screening
  • Presence of any concomitant autoimmune disease
  • Active or known history of catastrophic anti-phospholipid syndrome (APS)
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  • APS or thrombotic event not adequately controlled by anticoagulation therapy
  • History of progressive multifocal leukoencephalopathy
  • History of primary immunodeficiency or a hereditary deficiency of the complement system
  • Central nervous system (CNS) disease
  • Presence of 1 or more significant concurrent medical conditions per investigator judgment
  • Have a diagnosis or history of malignant disease within 5 years prior to Screening
  • Serious mental illness, alcohol or drug abuse, dementia, or any other condition that would impair the patient's ability to receive the planned treatment or to understand informed consent at the study site as determined by local practice
  • Inability to comply with protocol-mandated requirements
  • History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of study drug.
  • History of or planned organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation for the duration of the study.
  • Major surgery requiring use of general anesthesia within 12 weeks prior to Screening or planned or expected major surgery during the study period (from Screening to patient's last visit).
  • Any serious medical condition or abnormality on clinical laboratory testing
  • Women who are pregnant or breastfeeding.
  • Sexually active male patients who do not agree to refrain from donating semen

Trial locations and contacts

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

Qiubai Li, Professor contact

85726808 ext. 027

qiubaili@hust.edu.cn

Di Wu contact

+8618790696175 ext. 86

373181302@qq.com

China1 site

  • Wuhan Union Hospital

    Wuhan, Hubei, 430000

    Qiubai Li, Professor, 85726808 ext. 027, qiubaili@hust.edu.cn

    Lijuan Jiang, PhD, 85726808 ext. 027

Other trials in China

About this study

Official title: An Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of GB261 in Patients With Refractory Seropositive Systemic Lupus Erythematosus

The purpose of the study is to evaluate the safety and efficacy of CD20xCD3 T-cell engager (GB261) in patients with refractory seropositive systemic lupus erythematosus.

Read the detailed description

B cells play an important role in the pathogenesis of systemic lupus erythematosus (SLE). CD20 is a transmembrane receptor that is highly expressed on approximately 95% of B lineage cells. The use of anti-CD20 for B cell depletion represents a significant breakthrough in the treatment of B-cell-mediated autoimmune diseases. GB261 is a novel CD20/CD3 bispecific TCE that is designed to have very low affinity for CD3 and high affinity for CD20 to enable efficient T cell-mediated killing while minimizing risk of cytokine release syndrome (CRS). GB261 has shown promising safety and anti-tumor activity in a Phase 1/2 study in patients with relapsed/refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. GB261 offers a promising mechanism of action for SLE. This study aims to assess the safety, tolerability, PK, pharmacodynamics (PD), immunogenicity, and preliminary clinical activity of GB261 administered in patients with SLE. Patients will be invited to participate in the study, to receive GB261 intravenous infusion and monitored from the first dose of GB261 until Week 52.

Being tested
GB261
Keywords
Systemic Lupus Erythematosus, GB261
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.

  • GB261Biological

    GB261 will be dosed according to the assigned group.

Study groups in NCT06945068
Study groupRoleWhat they receive
GB261 intravenous interventionExperimentalGB261 will be administered by intravenous infusion, including 3 escalating dose levels and subsequent dose expansion. Timepoint of treatment: Day 1, Day 8 and Day 15. Anticipated enrollment: 9-18 participants in Dose Escalation group; 10 participants in Dose Expansion group.
Receives: Biological: GB261

What is being measured

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

  1. Safety and tolerability

    Incidence and severity of TEAEs through end of study. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are graded by ASTCT criteria, other AEs are assessed by CTCAE V5.0 criteria

    Measured: Baseline to Month 12

Secondary outcomes (4)

  1. Pharmacokinetics of GB261

    PK profiles and parameters, including Peak Plasma Concentration (Cmax), derived for GB261

    Measured: Baseline to Month 12 (Day1-4, 8-11, 15-18, 22, 29, 36 Week 8, 52)

  2. Pharmacokinetics of GB261

    PK profiles and parameters, including Area under the plasma concentration versus time curve (AUC), derived for GB261

    Measured: Baseline to Month 12 (Day1-4, 8-11, 15-18, 22, 29, 36 Week 8, 52)

  3. Pharmacokinetics of GB261

    PK profiles and parameters, including Time to Maximum Concentration (Tmax) derived for GB261

    Measured: Baseline to Month 12 (Day1-4, 8-11, 15-18, 22, 29, 36 Week 8, 52)

  4. Pharmacokinetics of GB261

    PK profiles and parameters, including Half-life (t½), derived for GB261

    Measured: Baseline to Month 12 (Day1-4, 8-11, 15-18, 22, 29, 36 Week 8, 52)

Timeline

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

  1. First posted25 Apr 2025
  2. Study startJun 2025 (estimated)
  3. Primary completionJun 2025 (estimated)
  4. Study completion30 Nov 2026 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06945068
Sponsor's protocol ID
UHCT250170
Status last verified
Apr 2025
First submitted
10 Apr 2025
Last updated
25 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GB261 in people with Systemic Lupus Erythematosus (SLE), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 20 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 25 Apr 2025. 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 Qiubai Li, Professor (85726808 ext. 027, qiubaili@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability (time frame: Baseline to Month 12). 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 NCT06945068.

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 25 Apr 2025.

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