Clinical Study of Cizutamig in Systemic Lupus Erythematosus
ConditionSystemic Lupus Erythematosus (SLE)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCandid Therapeutics
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cizutamig
Treatment groups
47 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov