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Cabaletta Bio Issued ID#NCT06328777 For Phase 1/2 Open-Label Study To Evaluate The Safety And Efficacy Of CABA-201, A CD19-CAR T Cell Therapy, In Subjects With Systemic Sclerosis Posted To Clinical Trials Website On 2024-03-25

Cabaletta Bio Issued ID#NCT06328777 For Phase 1/2 Open-Label Study To Evaluate The Safety And Efficacy Of CABA-201, A CD19-CAR T Cell Therapy, In Subjects With Systemic Sclerosis Posted To Clinical Trials Website On 2024-03-25

Cabaletta Bio 发布了 1/2 期开放标签研究的 ID #NCT06328777,该研究旨在评估 CD19-CAR T 细胞疗法 CABA-201 对系统性硬化症受试者的安全性和有效性 2024-03-25 发布在临床试验网站上
Benzinga ·  03/25 10:25

Inclusion Criteria:

纳入标准:

  • Age ≥18 and ≤70
  • A clinical diagnosis of SSc, based on the 2013 American College of Rheumatology and European League Against Rheumatism classification criteria.
  • Early active disease
  • Evidence of significant skin, pulmonary, renal, or cardiac involvement
  • 年龄 ≥18 且≤70
  • 根据2013年美国风湿病学会和欧洲抗风湿联盟的分类标准,对SSc进行临床诊断。
  • 早期活动性疾病
  • 有明显的皮肤、肺部、肾脏或心脏受累的证据

Exclusion Criteria:

排除标准:

  • Contraindication to leukapheresis
  • History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites
  • Active infection requiring medical intervention at screening visit
  • Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.
  • Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures
  • Severe lung or cardiac impairment
  • Previous CAR T cell therapy
  • Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant
  • 白血球置换术的禁忌症
  • 对氟达拉滨、环磷酰胺或其任何代谢物有过敏性或严重全身反应史
  • 活动性感染需要在筛查时进行医疗干预
  • 重度、进行性或不受控制的肾脏、肝脏、血液学、胃肠道、肺部、精神、心脏、神经系统或脑部疾病的当前症状,包括严重和不受控制的感染,例如败血症和机会性感染。
  • 研究人员认为,伴随的疾病可能会使受试者面临参与本研究的不可接受的风险,会干扰对研究产品的影响或安全性的评估或研究程序
  • 严重的肺部或心脏损伤
  • 以前的 CAR T 细胞疗法
  • 先前的实体器官(心脏、肝脏、肾脏、肺)移植或造血细胞移植

Other protocol-defined inclusion/exclusion criteria may apply.

其他协议定义的包含/排除标准可能适用。

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