Cizutamig treatment for people with systemic lupus erythematosus

A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Systemic Lupus Erythematosus

This study tests whether cizutamig is safe and shows early clinical benefit for adults with active SLE.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Candid Therapeutics (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT07215663 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–75 with ACR/EULAR‑defined SLE who are seropositive, have active disease (SLEDAI-2K total ≥6 and clinical ≥4), have had an inadequate response to prior treatment, and are on stable background therapies are the intended participants.

Not a fit: Patients with active infections, significant abnormal labs, other concomitant autoimmune diseases, catastrophic antiphospholipid syndrome, recent live vaccination, or who cannot stop excluded therapies are unlikely to benefit and are excluded.

Why it matters

Potential benefit: If successful, cizutamig could become a new treatment option that improves disease control for some patients with active SLE.

How similar studies have performed: While other immune‑targeting biologics have shown benefit in SLE, cizutamig itself is an early‑stage, novel agent with no large-scale efficacy data yet.

Eligibility criteria

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 this trial is running

Beijing

• Chinese Academy of Medical Sciences and Peking Union Medical College Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Liu Tian

Conditions Systemic Lupus Erythematosus