Study of YK012 in Moderate to Severe Systemic Lupus Erythematosus

NCT07010835 | Recruiting Phase 1

• 1 other identifier: YK012-4
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of YK012 in participants with Moderate to Severe Systemic Lupus Erythematosus (SLE).

Conditions

Systemic Lupus Erythematosus (SLE)

Outcome Measures

Primary Outcomes (4)

• Ib dose escalation stage: Dose Limiting Toxicity (DLT)

  From the first infusion of YK012 to Day 28 post first infusion

• Adverse Event (AE)

  An AE is defined as any untoward medical event that occurs after a participant receives the investigational drug, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the investigational drug.

  From the first infusion of YK012 to the end of trial at 48 weeks

• Severe Adverse Event (SAE)

  An SAE refers to any untoward medical occurrence after the participant receives the IMP that results in one or more of the following: death, life-threatening event, permanent or serious disability or loss of function, hospitalization or prolongation of hospitalization, congenital abnormalities or birth defects.

  From the first infusion of YK012 to the end of trial at 48 weeks

• Ib dose expansion stage and phase II: SRI-4 (Systemic Lupus Erythematosus Responder Index-4) response rates

  From the first infusion of YK012 to the end of trial at 48 weeks

Secondary Outcomes (31)

• Area Under the Curve (AUC0-t) of a serum concentration versus time profile

  From pre-dose of YK012 to the end of trial at 48 weeks

• Area under the blood concentration-time curve from zero to infinity (AUC0-∞)

  From pre-dose of YK012 to the end of trial at 48 weeks

• Maximum Concentration (Cmax) of YK012

  From pre-dose of YK012 to the end of trial at 48 weeks

• Time to Reach Cmax (Tmax)

  From pre-dose of YK012 to the end of trial at 48 weeks

• Elimination Half Life (t1/2)

  From pre-dose of YK012 to the end of trial at 48 weeks

Study Arms (1)

YK012

EXPERIMENTAL

Phase Ib: Participants will receive four different target doses of YK012 in dose escalation stage to evaluate its safety and tolerability. Participants will receive two to three different target doses of YK012 in dose expansion stage to further evaluate its safety, tolerability and effectiveness in reducing disease activity. Phase II: Participants will receive either placebo or one to two different doses of YK012. The specific doses will be determined based on prior clinical trial results.

Drug: YK012

Interventions

YK012 DRUG

YK012 is a bispecific antibody targeting CD19 and CD3.

YK012

Eligibility Criteria

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

You may qualify if:

• Aged 18 to 75 years (inclusive) at screening, regardless of sex
• Meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE, with a confirmed SLE diagnosis for at least 24 weeks at screening
• Positive for anti-dsDNA antibody and/or antinuclear antibody (ANA) and/or anti-Smith antibody at screening, as determined using the local laboratory's reference ranges at the study site
• Medium to high disease activity at screening, defined as: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥7
• Receiving stable background therapy at screening
• Capable of understanding and voluntarily participating in this clinical trial, having provided written informed consent, and able to comply with scheduled visits, treatments, examinations, and other study procedures.

You may not qualify if:

• Known allergy to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to the investigational drug or any of its components
• Received any anti-CD19/CD20 therapy or any B-cell depleting agents within 6 months prior to enrollment, or B-cell stimulatory factor inhibitors within 3 months or 5 half-lives prior to enrollment
• Received TNF inhibitors, interleukin receptor blockers, other small molecules or biologics within 3 months or 5 half-lives prior to enrollment
• Received intravenous immunoglobulins or plasmapheresis within 3 months prior to enrollment
• Used traditional Chinese medicines/herbal preparations for SLE treatment containing within 2 weeks prior to enrollment
• Received live or attenuated vaccines within 1 month prior to enrollment
• Has other autoimmune diseases, inflammatory joint diseases, or skin disorders (other than SLE) that may interfere with disease activity assessment
• History of malignancy within 5 years before screening, except for cured cases with no recurrence for at least 5 years, such as basal cell or squamous cell skin cancer, cervical carcinoma in situ, ductal carcinoma in situ of breast, or papillary thyroid cancer
• Clinically significant cardiovascular/cerebrovascular diseases within 6 months prior to screening
• Presence of QTcF interval prolongation on electrocardiogram (ECG)
• Presence of poorly controlled hypertension at screening
• History of non-SLE conditions requiring oral/intravenous/intramuscular/subcutaneous corticosteroid therapy (\>2 weeks) within 6 months prior to enrollment
• Active tuberculosis at screening or untreated latent tuberculosis
• History of solid organ or bone marrow transplantation
• Presence of active infections

Sponsors & Collaborators

• Excyte Biopharma Ltd: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xiaofeng Zeng, Doctor of Medicine

CONTACT

+86 13501069845; xiaofeng.zeng@cstar.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 8, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

CN (1)