Ulcerative Colitis (UC)Early Phase 1NCT07353450
A Study of Cizutamig for Patients With Ulcerative Colitis
A Early Phase 1 study testing cizutamig in people with Ulcerative Colitis (UC), run by Ruijin Hospital at 1 site in China.
Trial summary
A Study of Cizutamig for Patients with Ulcerative Colitis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- cizutamig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Jan 2026to Dec 2027
- Phase
- Early 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
- 18-75 years of age at the time of signing the informed consent form (ICF)
- Have an established diagnosis of UC
- Have current evidence of active moderate to severe UC.
- Have current evidence of UC extending proximal to the rectum
- Demonstrated intolerance or inadequate response to ≥ 1 biologic and/or other advanced therapies
- Stable use of any of the following background therapy (alone or in combination) up to Day 1
Show all 11Show fewer
- Have documentation of:
- A surveillance colonoscopy (performed according to local standards) within 12 months of or during Screening, for patients with pancolitis of > 8 years duration, left-sided colitis of > 12 years duration, or primary sclerosing cholangitis; OR
- In patients for whom Inclusion Criteria 7a does not apply, up-to-date colorectal cancer surveillance (performed according to local standard), for patients with family history of colorectal cancer, personal history of increased colorectal cancer risk, age > 50 years, or other known risk factors -
- Exclusion Criteria:1. Inadequate clinical laboratory parameters at Screening 2. Gastrointestinal disease 3. Patients with active infection 4. Receipt of or inability to discontinue any excluded therapies as specified in the protocol 5. Receipt of live vaccine within 4 weeks prior to Screening 6. History of progressive multifocal leukoencephalopathy 7. History of primary immunodeficiency or a hereditary deficiency of the complement system 8. Central nervous system (CNS) disease 9. Have presence of 1 or more significant concurrent medical conditions per investigator judgment 10. Have a diagnosis or history of malignant disease within 5 years prior to Screening 11. History of plasma cell dyscrasia 12. Need for uninterrupted anticoagulation 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 any constituents of cizutamig 16. History of severe allergic or anaphylactic reactions, or intolerance to required antimicrobial prophylaxis 17. History of or planned solid organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation for the duration of the study; or a corneal transplant within 12 weeks prior to Screening 18. Major surgery requiring use of general anesthesia within 12 weeks prior to Screening or planned or expected major surgery during the study period.
- 19. History of splenectomy, including patients with functional asplenia 20. Any serious medical condition or abnormality on clinical laboratory testing 21. Inability to comply with contraception requirements as specified in the protocol.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
Zu yan He, 17602156210, zuyan.he@caidya.com
About this study
Official title: An Open-Label, Single Center Study Evaluating the Safety, Tolerability, and Immunogenicity of Cizutamig for Patients With Moderate to Severe Ulcerative Colitis
A Study of Cizutamig for Patients with Ulcerative Colitis
Read the detailed description
An Open-Label, Single Center Study Evaluating the Safety, Tolerability, and Immunogenicity of Cizutamig for Patients with Moderate to Severe Ulcerative Colitis
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- cizutamig
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cizutamigBiological
Cizutamig will be dosed according to the protocol
| Study group | Role | What they receive |
|---|---|---|
| A Study of Cizutamig for Patients with Ulcerative Colitis | Experimental | Cizutamig intravenous intervention Receives: Biological: cizutamig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
- Incidence of treatment-emergent adverse events (TEAEs) through end of study.
- Severity Grade of treatment-emergent adverse events (TEAEs) through end of study.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353450
- Sponsor's protocol ID
- CND106-RUJN-2
- Status last verified
- Dec 2025
- First submitted
- 26 Dec 2025
- Last updated
- 20 Jan 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 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single Center Study Evaluating the Safety, Tolerability, and Immunogenicity of Cizutamig for Patients With Moderate to Severe Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT07353450
- Acronym / sponsor ID
- CND106-RUJN-2
- Conditions
- Ulcerative Colitis (UC)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Jan 2026 (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.
A Study of Cizutamig for Patients with Ulcerative Colitis
Detailed description
An Open-Label, Single Center Study Evaluating the Safety, Tolerability, and Immunogenicity of Cizutamig for Patients with Moderate to Severe Ulcerative Colitis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A Study of Cizutamig for Patients with Ulcerative Colitis | Experimental | Biological: cizutamigCizutamig intravenous intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18-75 years of age at the time of signing the informed consent form (ICF)
- Have an established diagnosis of UC
- Have current evidence of active moderate to severe UC.
- Have current evidence of UC extending proximal to the rectum
- Demonstrated intolerance or inadequate response to ≥ 1 biologic and/or other advanced therapies
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| cizutamigCizutamig will be dosed according to the protocol | Biological | A Study of Cizutamig for Patients with Ulcerative Colitis |
Primary outcome
Safety and tolerability
Time frame: Week 52
1. Incidence of treatment-emergent adverse events (TEAEs) through end of study. 2. Severity Grade of treatment-emergent adverse events (TEAEs) through end of study.
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 20 Jan 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing cizutamig in people with Ulcerative Colitis (UC), run by Ruijin Hospital at 1 site 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 11 inclusion and 0 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: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Duo wu Zou (13901617608, zdw_pi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: Week 52). 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 20 Jan 2026.