NCT07215663 Clinical Study of Cizutamig in Systemic Lupus Erythematosus
| NCT ID | NCT07215663 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Candid Therapeutics |
| Condition | Systemic Lupus Erythematosus (SLE) |
| Study Type | INTERVENTIONAL |
| Enrollment | 47 participants |
| Start Date | 2025-09-04 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 47 participants in total. It began in 2025-09-04 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07215663 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Systemic Lupus Erythematosus (SLE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07215663 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07215663 currently recruiting?
Yes, NCT07215663 is actively recruiting participants. Contact the research team at liu@candidrx.com for enrollment information.
Where is the NCT07215663 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07215663 clinical trial?
NCT07215663 is sponsored by Candid Therapeutics. The trial plans to enroll 47 participants.
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