Systemic Lupus Erythematosus (SLE)Phase 1NCT07215663
Clinical Study of Cizutamig in Systemic Lupus Erythematosus
A Phase 1 study testing Cizutamig in people with Systemic Lupus Erythematosus (SLE), run by Candid Therapeutics at 17 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- What is being tested?
- Cizutamig
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 17 sitesChina
- Study dates
- 4 Sep 2025to Apr 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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)
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
China17 sites, 17 recruiting
- Recruiting
Chinese Academy of Medical Sciences and Peking Union Medical College Hospital
Beijing, Beijing Municipality
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
- Recruiting
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
- Recruiting
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
- Recruiting
Henan University of Science and Technology-The First Affiliated Hospital
Luoyang, Henan
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
- Recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning
- Recruiting
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
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
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
Read the 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)
- Being tested
- Cizutamig
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CizutamigDrug
Also called CND106
Cizutamig will be dosed according to the protocol
| Study group | Role | What they receive |
|---|---|---|
| Cizutamig | Experimental | Not described Receives: Drug: Cizutamig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events through end of study
Measured: Baseline to Month 12
Changes from baseline in vital signs through end of study: body temperature
Measured: Baseline to Month 12
Changes from baseline in vital signs through end of study: heart rate
Measured: Baseline to Month 12
Changes from baseline in vital signs through end of study: respiratory rate
Measured: Baseline to Month 12
Changes from baseline in vital signs through end of study: blood pressure
Measured: Baseline to Month 12
Changes from baseline in vital signs through end of study: pulse oximetry
Measured: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: PR interval
Measured: Baseline to Month12
Changes from baseline in ECG parameters through end of study: QRS interval
Measured: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QTcF interval
Measured: Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study: serum chemistry
Measured: Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study: hematology
Measured: Baseline to Month 12
Secondary outcomes (6)
Pharmacokinetic (PK) for Cizutamig: Cmax
Measured: Baseline to Month 12
PK parameters for Cizutamig: time of maximum concentration
Measured: Baseline to Month 12
PK parameters for Cizutamig: area under the concentration-time curve
Measured: Baseline to Month 12
PK parameters for Cizutamig: clearance
Measured: Baseline to Month 12
PK parameters for Cizutamig: volume of distribution
Measured: Baseline to Month 12
PK parameters for Cizutamig: half-life
Measured: Baseline to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study start4 Sep 2025
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Candid Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215663
- Sponsor's protocol ID
- CND106-103
- Status last verified
- Aug 2026
- First submitted
- 23 Sep 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07215663
- Acronym / sponsor ID
- CND106-103
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Candid TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 10 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cizutamig | Experimental | Drug: Cizutamig |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CizutamigAlso: CND106Cizutamig will be dosed according to the protocol | Drug | Cizutamig |
Primary outcome
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
Changes from baseline in safety laboratory assessments through end of study: hematology
Time frame: Baseline to Month 12
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cizutamig in people with Systemic Lupus Erythematosus (SLE), run by Candid Therapeutics at 17 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liu Tian (+86 17621830227, liu@candidrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events through end of study (time frame: Baseline to Month 12). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.