NCT07512947

Study of YKST02 Alone or in Combination With YK012 in Patients With Active or Refractory Systemic Lupus Erythematosus

A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of YKST02 as Monotherapy or in Combination With YK012 in Patients With Active or Refractory Systemic Lupus Erythematosus

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of YKST02 administered alone or in combination with YK012 in participants with active or refractory systemic lupus erythematosus (SLE). The main questions this study aims to address are: * Whether YKST02 alone or in combination with YK012 is safe and well tolerated in participants with active or refractory SLE * Whether YKST02 alone or in combination with YK012 demonstrates preliminary efficacy in treating SLE * What the PK and PD characteristics of YKST02 are when administered alone or in combination with YK012 * Whether treatment with YKST02 induces anti-drug antibody responses Participants will: * Receive intravenous infusions of YKST02 alone or in combination with YK012 according to the assigned cohort * Undergo safety assessments, including monitoring for adverse events * Provide blood samples for PK, PD, and immunogenicity analyses * Be followed for approximately 49 weeks to assess safety and efficacy

Detailed description

This is a single-center, open-label clinical trial evaluating YKST02 administered alone or in combination with YK012 in participants with active or refractory systemic lupus erythematosus (SLE). The study is designed to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy. The study consists of two cohorts: Cohort 1 (YKST02 Monotherapy): Participants will receive YKST02 as a single agent to evaluate its safety, tolerability, and preliminary efficacy. Cohort 2 (Combination Therapy): Participants will receive YKST02 in combination with YK012. This cohort includes a dose-escalation phase to evaluate safety and tolerability across dose levels, followed by a dose-expansion phase to further evaluate safety and preliminary efficacy at selected dose levels. The study includes a screening period, a treatment period during which participants receive study drugs by intravenous infusion, and a follow-up period for safety and efficacy assessments. Safety evaluations include monitoring of adverse events, clinical laboratory tests, and other safety parameters. PK and PD assessments will be performed to characterize drug exposure and biological activity. Immunogenicity will be evaluated by assessing anti-drug antibody responses. Exploratory analyses may include evaluation of immune cell populations, cytokines, and other biomarkers to further characterize the biological effects of the study treatments.

Conditions

• System Lupus Erythematosus(SLE)

Interventions

Type	Name	Description
DRUG	YKST02	YKST02 is administered by intravenous (IV) infusion.
DRUG	YK012	YK012 is administered by intravenous (IV) infusion in combination with YKST02.

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-03-30
• Completion: 2028-06-30
• First posted: 2026-04-06
• Last updated: 2026-04-06

Locations

1 site across 1 country: China