CTIS2023-509892-17-00进行中（未招募）1 期
A Phase 2, Open-Label, Multicentre Study of KYV-101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Generalized Myasthenia Gravis (KYSA-6) - KYV101-006
Kyverna Therapeutics Inc.0 个研究点目标入组 20 人开始时间: 2024年1月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Diagnosis of MG with presence of autoantibodies to AChR and MuSK, Myasthenia Gravis Foundation of America (MGFA) Class IIB-IV
排除标准
- •Prior treatment with cellular immunotherapy (CAR-T) or gene therapy product directed at any target, History of allogeneic or autologous stem cell transplant, Evidence of active hepatitis B or hepatitis C infection, Positive serology for HIV, Primary immunodeficiency, History of splenectomy, History of stroke, seizure, dementia, Parkinson’s disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder investigator considers would increase the risk for the subject, Impaired cardiac function or clinically significant cardiac disease, Previous or concurrent malignancy with the following exceptions: a. Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to screening). b. In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening. c. A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 5 years prior to screening.
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