NCT06945068
An Open-label Study of GB261 in Refractory Seropositive Systemic Lupus Erythematosus
Not Yet Recruiting · Phase 1 · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · registry updated 2025-04-25
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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
Exclusion
- 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)