Systemic Lupus Erythematosus (SLE)
Conditions
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
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
DRUGCizutamig
Cizutamig will be dosed according to the protocol
Sponsors
Candid Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment-emergent adverse events through end of study | Baseline to Month 12 |
| Changes from baseline in vital signs through end of study: body temperature | Baseline to Month 12 |
| Changes from baseline in vital signs through end of study: heart rate | Baseline to Month 12 |
| Changes from baseline in vital signs through end of study: respiratory rate | Baseline to Month 12 |
| Changes from baseline in vital signs through end of study: blood pressure | Baseline to Month 12 |
| Changes from baseline in vital signs through end of study: pulse oximetry | Baseline to Month 12 |
| Changes from baseline in ECG parameters through end of study: PR interval | Baseline to Month12 |
| Changes from baseline in ECG parameters through end of study: QRS interval | Baseline to Month 12 |
| Changes from baseline in ECG parameters through end of study: QTcF interval | Baseline to Month 12 |
| Changes from baseline in safety laboratory assessments through end of study: serum chemistry | Baseline to Month 12 |
| Changes from baseline in safety laboratory assessments through end of study: hematology | Baseline to Month 12 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) for Cizutamig: Cmax | Baseline to Month 12 |
| PK parameters for Cizutamig: time of maximum concentration | Baseline to Month 12 |
| PK parameters for Cizutamig: area under the concentration-time curve | Baseline to Month 12 |
| PK parameters for Cizutamig: clearance | Baseline to Month 12 |
| PK parameters for Cizutamig: volume of distribution | Baseline to Month 12 |
| PK parameters for Cizutamig: half-life | Baseline to Month 12 |
Countries
China
Contacts
CONTACTLiu Tian
Outcome results
None listed