A Study of Cizutamig for Patients With Ulcerative Colitis
Early Phase 1 · Testing cizutamig · 1 site · Ruijin Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing cizutamig (a biologic) as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC).
It is open-label: participants know what they are receiving.
Early Phase 1 studies are very small first studies in people, mainly checking safety and how the body handles a treatment.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 6 more requirement(s). There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 15 participants are expected to take part.
- Start date: 2026-01 (planned).
- Main results expected around 2027-12 (estimate from the record).
- 1 study site listed in China.
Main thing being measured
- Safety and tolerability (Week 52)
In the researchers’ words
A Study of Cizutamig for Patients with Ulcerative Colitis
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Early Phase 1 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC) |
| Lead sponsor | Ruijin Hospital |
| Enrollment | 15 (estimated) |
| Start date | 2026-01 |
| Primary completion (est.) | 2027-12 |
| First posted | 2026-01-20 |
| Last updated | 2026-01-20 |
| 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 |
Interventions
- cizutamig (Biological)
Cizutamig will be dosed according to the protocol
Full eligibility criteria (from the record)
Inclusion Criteria: 1. 18-75 years of age at the time of signing the informed consent form (ICF) 2. Have an established diagnosis of UC 3. Have current evidence of active moderate to severe UC. 4. Have current evidence of UC extending proximal to the rectum 5. Demonstrated intolerance or inadequate response to ≥ 1 biologic and/or other advanced therapies 6. Stable use of any of the following background therapy (alone or in combination) up to Day 1 7. Have documentation of: 1. 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 2. 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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | China |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.