Clinical Study of Cizutamig in Systemic Lupus Erythematosus

NCT ID: NCT07215663

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-04
• Study Completion Date: 2028-04-30

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

Conditions

Systemic Lupus Erythematosus (SLE)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cizutamig

Group Type: EXPERIMENTAL

Cizutamig

Intervention Type: DRUG

Cizutamig will be dosed according to the protocol

Interventions

Cizutamig

Cizutamig will be dosed according to the protocol

Intervention Type: DRUG

Other Intervention Names

CND106

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Candid Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chinese Academy of Medical Sciences and Peking Union Medical College Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Liu Tian

Role: CONTACT

liu@candidrx.com

+86 17621830227

Other Identifiers

CND106-103

Identifier Type: -

Identifier Source: org_study_id