NCT07353450尚未招募1 期
An Open-Label, Single Center Study Evaluating the Safety, Tolerability, and Immunogenicity of Cizutamig for Patients With Moderate to Severe Ulcerative Colitis
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 15
研究概览
简要总结
A Study of Cizutamig for Patients with Ulcerative Colitis
详细描述
An Open-Label, Single Center Study Evaluating the Safety, Tolerability, and Immunogenicity of Cizutamig for Patients with Moderate to Severe Ulcerative Colitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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 -
排除标准
- •Inadequate clinical laboratory parameters at Screening
- •Gastrointestinal disease
- •Patients with active infection
- •Receipt of or inability to discontinue any excluded therapies as specified in the protocol
- •Receipt of live vaccine within 4 weeks prior to Screening
- •History of progressive multifocal leukoencephalopathy
- •History of primary immunodeficiency or a hereditary deficiency of the complement system
- •Central nervous system (CNS) disease
- •Have presence of 1 or more significant concurrent medical conditions per investigator judgment
- •Have a diagnosis or history of malignant disease within 5 years prior to Screening
- •History of plasma cell dyscrasia
- •Need for uninterrupted anticoagulation
- •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 any constituents of cizutamig
- •History of severe allergic or anaphylactic reactions, or intolerance to required antimicrobial prophylaxis
- •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
- •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
- •Any serious medical condition or abnormality on clinical laboratory testing
- •Inability to comply with contraception requirements as specified in the protocol.
研究者
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