Cizutamig treatment for people with systemic lupus erythematosus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1b, open-label, multicenter study testing cizutamig in adults with systemic lupus erythematosus to characterize safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity. Eligible participants are 18–75 years old with SLE by ACR/EULAR criteria, seropositivity (anti-dsDNA or anti‑Smith plus another antibody/ANA ≥1:80), and active disease defined by SLEDAI-2K thresholds; selected patients with active class III/IV lupus nephritis may be included. The protocol requires stable background therapies and excludes patients with active infection, significant lab abnormalities, other autoimmune diseases, catastrophic antiphospholipid syndrome, recent live vaccines, or disallowed concurrent treatments. The study is conducted at Peking Union Medical College Hospital in Beijing and will collect safety and PK/PD data alongside exploratory measures of clinical activity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18 to 75 years old at the time of signing the informed consent form
2. Diagnosis of SLE according to the ACR/EULAR classification criteria
3. Positive anti-dsDNA or positive anti-Smith antibodies AND positive for at least one other of anti-dsDNA, anti-Smith antibodies, or ANA ≥1:80 at screening
4. SLEDAI-2K total score ≥6 and SLEDAI-2K clinical score≥4 at Screening
5. The investigator judged that the patient had an inadequate response to prior treatment for at least 3 months before screening
6. Stable use of concomitant therapies
7. For patients with active LN only: LN Class III or IV

Exclusion Criteria:

1. Inadequate clinical laboratory parameters at Screening
2. Active infection
3. Receipt of or inability to discontinue any excluded therapies
4. Receipt of live vaccine within 4 weeks prior to Screening
5. Presence of any concomitant autoimmune disease
6. Active or known history of catastrophic anti-phospholipid syndrome (APS)
7. APS or thrombotic event not adequately controlled by anticoagulation therapy
8. History of progressive multifocal leukoencephalopathy
9. History of primary immunodeficiency or a hereditary deficiency of the complement system
10. Central nervous system disease
11. Presence of 1 or more significant concurrent medical conditions
12. Have a diagnosis or history of malignant disease within 5 years
13. 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
14. Inability to comply with protocol-mandated requirements
15. History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of cizutamig
16. History of or planned organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation
17. Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study
18. Women who are pregnant or breastfeeding
19. Patients who do not agree to the use of highly effective contraception as defined by the protocol
20. Individuals considered to be part of a vulnerable population (eg, incarceration)

Where it's running

• Chinese Academy of Medical Sciences and Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting
• Nanfang Hospital Southern Medical University
  Guangzhou, Guangdong, China Recruiting
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• The First Affiliated Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• The Third Affiliated Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Liu Tian
• Email: liu@candidrx.com
• Phone: +86 17621830227

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.