NCT06212154招募中1 期
The Safety and Efficacy of ThisCART19A for Relapsed/Refractory Autoimmune Hemolytic Anemia Patients After Receiving Three or More Lines of Therapy.
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2024年1月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Maximal Tolerable Dose(MTD)
研究概览
简要总结
To Evaluate the Safety and Efficacy of ThisCART19A for Relapsed/Refractory Autoimmune Hemolytic Anemia Patients After Receiving Three or More Lines of Therapy
详细描述
This is a phase 1, single-arm, open-label, dose-escalation and dose-expansion study. The main purpose is to evaluate the safety and tolerability, efficacy, pharmacokinetics and pharmacodynamics of ThisCART19A in patients with autoimmune hemolytic anemia who have failed ≥3 lines of therapy, which include glucocorticoids, rituximab, cyclophosphamide, azathioprine, fludarabine, cyclosporine, mycophenolate mofetil, BTK inhibitors, splenectomy, etc. Participants will receive ThisCART19A cell infusion after preconditioning, and they need to be closely monitored for 28 days following CAR-T cell infusion.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject and/or subject's legal personal representative fully understand and voluntarily sign informed consent forms.
- •Male or female age ≥ 12 years.
- •ECOG performance status ≤
- •Diagnosis of warm antibody hemolytic anemia (AIHA), cold AIHA, mixed AIHA or Evans syndrome.
- •Hemoglobin<100g/L.
- •Failure or intolerance to at least 3 lines of therapy, including glucocorticoids, rituximab, cyclophosphamide, azathioprine, fludarabine, cyclosporine, mycophenolate mofetil, Bruton's tyrosine kinase inhibitors, splenectomy.
- •Laboratory tests of adequate organ function: Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; Creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥40ml/min; Absolute neutrophil count (ANC) ≥1.0×10^9/L (growth factors such as granulocyte colony-stimulating factor [G-CSF] were not received within 7 days before the screening period); Left ventricular ejection fraction (LVEF) ≥45%; Blood oxygen saturation (SpO2) ≥92%.
- •Subjects of childbearing potential will be required to follow contraception requirements from the time of enrollment until the end of the 6-month safety follow-up period. Female subjects of childbearing potential must have a negative Serum HCG test within 7 days before enrollment and not in the lactation period.
排除标准
- •Clear diagnosis of lymphoproliferative tumor.
- •The platelet count in peripheral blood during the screening period is <20×10^9/L.
- •Have a history of severe drug allergy or allergic constitution.
- •Have a history of any of the following diseases: craniocerebral trauma, consciousness disorder, epilepsy, cerebrovascular ischemia, cerebrovascular, and hemorrhagic diseases within 6 months before enrollment.
- •Have any of the following serious cardiovascular diseases: myocardial infarction within 6 months before enrollment, cardiac angioplasty or stent implantation); Unstable angina; Severe cardiac arrhythmias; History of severe nonischemic cardiomyopathy; Congestive heart failure (New York Heart Association [NYHA] Class III or IV)).
- •Have malignant tumors within 5 years before enrollment, unless any of the following conditions: fully treated cervical carcinoma in situ, fully treated basal cell or squamous epithelial cell skin cancer, localized prostate cancer after radical mastectomy, breast ductal carcinoma in situ after radical mastectomy, Carcinoma in situ in other locations one year after radical resection, and these diseases have no evidence of relapse.
- •Subjects with any serious active fungal, bacterial, viral, tuberculosis or other infections, including active hepatitis B (defined as serum HBV-DNA ≥ 2000 IU/mL), active hepatitis C virus (Hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV) antibody-positive or active syphilis patients, etc. Subjects whose HBV-DNA < 2000 IU/mL can be included on the condition that they receive antiviral drugs and monitor the related indicators during the study.
- •Have mental illness and severe cognitive impairment.
- •Have a history of live attenuated vaccines within 4 weeks before enrollment.
- •Subjects considered to be ineligible for the study by the investigator for reasons other than the above.
结局指标
主要结局
Maximal Tolerable Dose(MTD)
时间窗: Up to 28 days after infusion
MTD is classified by the NCI CTCAE V5.0
The incidence and frequency of treatment-emergent adverse events
时间窗: Within 6 months
次要结局
- Time to response (TTR)(Within 6 months)
- Best response rate (BOR) of each dose group(Within 12 weeks after infusion)
- Objective response rate (ORR)(Within 4 weeks after infusion)
研究者
Jun Shi
Director of Regenerative Medicine Center
Institute of Hematology & Blood Diseases Hospital, China
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell LymphomaB Cell LymphomaNCT03101709Henan Cancer Hospital30
Unknown
1 期
Phase I Study of CD19-CAR-T2 Cells for Patients With Chemotherapy Resistant or Refractory CD19+ Acute LeukemiaAcute LeukemiaNCT02822326Guangdong Provincial People's Hospital30
Unknown
不适用
CAR-T Treatment for Relapse / Refractory Type Safety and Effectiveness of LymphomaLymphomaNCT03488160Sinobioway Cell Therapy Co., Ltd.6
招募中
1 期
Safety and Efficacy Study of CD19-CAR-DNT Cells in Autoimmune DiseasesAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisIdiopathic Inflammatory MyopathiesSystemic Lupus ErythematosusSystemic SclerosisNCT06316076RenJi Hospital48
Unknown
1 期
Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B-NHL After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) TherapyNon-Hodgkin's LymphomaNCT05349266Zhejiang University16