RecruitingPhase 1NCT07215663

Clinical Study of Cizutamig in 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

Sponsor

Candid Therapeutics

Enrollment

47 participants

Start Date

Sep 4, 2025

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus (SLE)

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

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 Criteria20

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 by local practice
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)