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

NCT07512947 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-06

No results posted yet for this study

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

Conditions

  • System Lupus Erythematosus(SLE)

Interventions

DRUG

YKST02

YKST02 is administered by intravenous (IV) infusion.

DRUG

YK012

YK012 is administered by intravenous (IV) infusion in combination with YKST02.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Qiubai Li, MD, PhD · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-03-30
Completion
2028-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07512947 on ClinicalTrials.gov