Clinical Study of Cizutamig in Systemic Lupus Erythematosus

Official title

A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Systemic Lupus Erythematosus

Overview

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

Detailed description

This is a Phase 1b, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of cizutamig in patients with Systemic Lupus Erythematosus

Interventions

• Drug Cizutamig
  Cizutamig will be dosed according to the protocol

Primary outcome measures

• Incidence and severity of treatment-emergent adverse events through end of study [Time frame: Baseline to Month 12]
• Changes from baseline in vital signs through end of study: body temperature [Time frame: Baseline to Month 12]
• Changes from baseline in vital signs through end of study: heart rate [Time frame: Baseline to Month 12]
• Changes from baseline in vital signs through end of study: respiratory rate [Time frame: Baseline to Month 12]
• Changes from baseline in vital signs through end of study: blood pressure [Time frame: Baseline to Month 12]
• Changes from baseline in vital signs through end of study: pulse oximetry [Time frame: Baseline to Month 12]
• Changes from baseline in ECG parameters through end of study: PR interval [Time frame: Baseline to Month12]
• Changes from baseline in ECG parameters through end of study: QRS interval [Time frame: Baseline to Month 12]
• Changes from baseline in ECG parameters through end of study: QTcF interval [Time frame: Baseline to Month 12]
• Changes from baseline in safety laboratory assessments through end of study: serum chemistry [Time frame: Baseline to Month 12]

Secondary outcome measures (6)

• Pharmacokinetic (PK) for Cizutamig: Cmax [Time frame: Baseline to Month 12]
• PK parameters for Cizutamig: time of maximum concentration [Time frame: Baseline to Month 12]
• PK parameters for Cizutamig: area under the concentration-time curve [Time frame: Baseline to Month 12]
• PK parameters for Cizutamig: clearance [Time frame: Baseline to Month 12]
• PK parameters for Cizutamig: volume of distribution [Time frame: Baseline to Month 12]
• PK parameters for Cizutamig: half-life [Time frame: Baseline to Month 12]

Eligibility criteria

Inclusion 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

Exclusion criteria

• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Chinese Academy of Medical Sciences and Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT07215663 · CND106-103

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗