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New treatment option for Systemic Lupus Erythematosus (SLE)
Official title Clinical Study of Cizutamig in Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT07215663
What this study is testing
What is Cizutamig?
Cizutamig is an investigational medicine, being studied as a potential treatment for systemic lupus erythematosus (sle).
Also referred to as CND106.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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
You likely can't join if
- Inadequate clinical laboratory parameters at Screening
- Active infection
- 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
- Active or known history of catastrophic anti-phospholipid syndrome (APS)
See the full eligibility criteria
- 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
- Inadequate clinical laboratory parameters at Screening
- Active infection
- 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
- Active or known history of catastrophic anti-phospholipid syndrome (APS)
- APS or thrombotic event not adequately controlled by anticoagulation therapy
- History of progressive multifocal leukoencephalopathy
- History of primary immunodeficiency or a hereditary deficiency of the complement system
- Central nervous system disease
- Presence of 1 or more significant concurrent medical conditions
- 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...
- Inability to comply with protocol-mandated requirements
- 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
- Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.