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

NCT06945068 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: UHCT250170
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Systemic Lupus Erythematosus (SLE)

Keywords

Systemic Lupus Erythematosus; GB261

Outcome Measures

Primary Outcomes (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

  Baseline to Month 12

Secondary Outcomes (4)

• Pharmacokinetics of GB261

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

• Pharmacokinetics of GB261

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

• Pharmacokinetics of GB261

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

• Pharmacokinetics of GB261

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

Other Outcomes (6)

• Pharmacodynamics of GB261

  Baseline to Month 12(Screening, Day1, Day 8, 15, 22, 29, 36, Week 8, 16, 24, 36, 52)

• Pharmacodynamics of GB261

  Baseline to Month 12(Screening, Day1, Day 8, 15, 22, 29, 36, Week 52)

• Immunogenicity of GB261

  Baseline to Month 12 (Day1, Day 8, 15, 22, 29, 36, Week 8, 12, 16, 24, 52)

Study Arms (1)

GB261 intravenous intervention

EXPERIMENTAL

GB261 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.

Biological: GB261

Interventions

GB261 BIOLOGICAL

GB261 will be dosed according to the assigned group.

GB261 intravenous intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \. 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
• Current and stable use of some medication must be discontinued ≥1 week prior to Day 1
• 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Qiubai Li, Professor

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiubai Li, Professor

CONTACT

85726808; qiubaili@hust.edu.cn

Di Wu

CONTACT

+8618790696175; 373181302@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Department of Rheumatology and Immunology, Principal Investigator, Professor, Wuhan Union Hospital

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 25, 2025
• Study Start: June 1, 2025
• Primary Completion: June 1, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)