Testing cizutamig in people with systemic lupus erythematosus
Tests cizutamig for safety and early effects in adults with lupus.
Plain-language title generated from the registry record
Registry title: Clinical Study of Cizutamig in Systemic Lupus Erythematosus
Key facts
- Where
- Beijing, Changsha, Chengdu, Guangzhou, Luoyang, Nanchang, Shanghai, Shenyang, Taiyuan, Tianjin, Xi'an, and Zhengzhou, ChinaSee the 17 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07215663, who can take part
Where in China
- Chinese Academy of Medical Sciences and Peking Union Medical College HospitalBeijing, ChinaTaking people
- Xiangya Hospital of Central South UniversityChangsha, ChinaTaking people
- West China Hospital of Sichuan UniversityChengdu, ChinaTaking people
- Guangdong Provincial People's HospitalGuangzhou, ChinaTaking people
- Nanfang Hospital, Southern Medical UniversityGuangzhou, ChinaTaking people
- Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityGuangzhou, ChinaTaking people
- The First Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaTaking people
- The Third Affiliated Hospital,Sun Yat-Sen UniversityGuangzhou, ChinaTaking people
- Henan University of Science and Technology-The First Affiliated HospitalLuoyang, ChinaTaking people
- The First Affiliated Hospital of NanChang UniversityNanchang, ChinaTaking people
- The Second Affiliated Hospital of Nanchang UniversityNanchang, ChinaTaking people
- Renji Hospital Shanghai Jiao Tong University School of MedicineShanghai, ChinaTaking people
- The First Hospital of China Medical UniversityShenyang, ChinaTaking people
- Second hospital of Shanxi Medical UniversityTaiyuan, ChinaTaking people
- Tianjin Medical University General HospitalTianjin, ChinaTaking people
- The Second Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, ChinaTaking people
- The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Candid Therapeutics
- Trial code
- NCT07215663
- Record updated
- 2 September 2026
- Original description
The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of Cizutamig in patients with Systemic Lupus ErythematosusRead full original descriptionShow less
A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Systemic Lupus Erythematosus
The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of Cizutamig in patients with Systemic Lupus Erythematosus
Inclusion: 18 to 75 years old at the time of signing the informed consent form; Diagnosis of SLE according to the ACR/EULAR classification criteria; 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; SLEDAI-2K total score ≥6 and SLEDAI-2K clinical score≥4 at Screening; The investigator judged that the patient had an inadequate response to prior treatment for at least 3 months before screening; Stable use of concomitant therapies; For patients with active LN only: LN Class III or IV.
Exclusion: Receipt of or inability to discontinue any excluded therapies; Receipt of live vaccine within 4 weeks prior to Screening; Presence of any concomitant autoimmune disease; APS or thrombotic event not adequately controlled by anticoagulation therapy; Presence of 1 or more significant concurrent medical conditions; Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study; Active infection; Active or known history of catastrophic anti-phospholipid syndrome (APS); History of progressive multifocal leukoencephalopathy; History of primary immunodeficiency or a hereditary deficiency of the complement system; Central nervous system disease; Have a diagnosis or history of malignant disease within 5 years; 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; History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of cizutamig; History of or planned organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation; Inadequate clinical laboratory parameters at Screening; Inability to comply with protocol-mandated requirements; Women who are pregnant or breastfeeding; Patients who do not agree to the use of highly effective contraception as defined by the protocol; Individuals considered to be part of a vulnerable population (eg, incarceration).