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; Study Is Not Yet Recruiting
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; Study Is Not Yet Recruiting
Cabaletta Bio 發佈了 1/2 期開放標籤研究的 ID #NCT06328777，該研究旨在評估 CD19-CAR T 細胞療法 CABA-201 對系統性硬化症受試者的安全性和有效性，該研究於 2024-03-25 發佈在臨床試驗網站上；該研究尚未招募人士
Inclusion Criteria:
納入標準：
- 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
- 年齡 ≥18 且≤70
- 根據2013年美國風溼病學會和歐洲抗風溼聯盟的分類標準，對SSc進行臨床診斷。
- 早期活動性疾病
- 有明顯的皮膚、肺部、腎臟或心臟受累的證據
Exclusion Criteria:
排除標準：
- 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
- 白血球置換術的禁忌症
- 對氟達拉濱、環磷酰胺或其任何代謝物有過敏性或嚴重全身反應史
- 活動性感染需要在篩查時進行醫療干預
- 重度、進行性或不受控制的腎臟、肝臟、血液學、胃腸道、肺部、精神、心臟、神經系統或腦部疾病的當前症狀，包括嚴重和不受控制的感染，例如敗血症和機會性感染。
- 研究人員認爲，伴隨的疾病可能會使受試者面臨參與本研究的不可接受的風險，會干擾對研究產品的影響或安全性的評估或研究程序
- 嚴重的肺部或心臟損傷
- 以前的 CAR T 細胞療法
- 先前的實體器官（心臟、肝臟、腎臟、肺）移植或造血細胞移植
Other protocol-defined inclusion/exclusion criteria may apply.
其他協議定義的包含/排除標準可能適用。
譯文內容由第三人軟體翻譯。
以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。