NCT06231368进行中（未招募）1 期
The Safety and Efficacy of CNCT19 for Patients With Autoimmune Hemolytic Anemia After Failure of 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 6 人开始时间: 2024年2月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Incidence and the severity of the adverse event
研究概览
简要总结
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 of CNCT19 CAR T-cell therapy in patients with autoimmune hemolytic anemia after failure of three or more lines of therapy. Participants will receive CNCT19 cell infusion after preconditioning, and they will receive a 1-year follow-up.
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
- •Subjects with autoimmune hemolytic anemia or Evans syndrome after Failure ≥3 lines of therapy. The Failure of ≥3 lines of therapy meets all the following conditions: Hemoglobin less than 10g/dl and symptoms of anemia; Failure of first-line corticosteroid therapy; Failure of second-line rituximab therapy; Failure of any one or more of the third-line treatments (splenectomy, cyclosporine, cyclophosphamide, azathioprine, mycophenolate mofetil, fludarabine, bortezomib, etc.)
- •Female subjects of childbearing potential must have a negative Serum HCG test within 7 days before enrollment. Subjects of childbearing potential will be required to follow contraception requirements from the time of enrollment until the 1-year follow-up after cell infusion
- •Laboratory tests of adequate organ function: Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; and have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and the blood oxygen saturation in a non-oxygenated state is >93%
- •ECOG performance status ≤2
- •Subject with a life expectancy of more than 3 months
排除标准
- •History of other lymphoproliferative neoplasms
- •Secondary AIHA caused by drugs or infection
- •Platelets in subjects with Evans syndrome<30×10^9/L
- •Pregnant or breast-feeding subjects
- •Treatment with any of the following within the noted period prior to study entry: a.anti-CD20 monoclonal antibodies <12 weeks, b.sutimlimab or other marketed biologics <5 half-lives; c.plasma exchange <4 weeks; d.post-splenectomy <12 weeks
- •Previously received organ or stem cell transplantation
- •History of new thrombosis or organ infarction in the past 6 months
- •Diagnosis of the active stage of the connective tissue disease
- •Had other inherited or acquired hemolytic diseases
- •Have active infections, such as sepsis, bacteremia, fungemia, uncontrolled pulmonary infection and active tuberculosis, etc.
- •Positive hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg); positive hepatitis B e antibody (HBe-Ab) or hepatitis B core antibody (HBc-Ab), and the HBV-DNA copy number is above the lower limit of the measurable capacity; positive hepatitis C (HCV) antibody; positive human immunodeficiency virus (HIV) antibody; positive syphilis test
- •Received major surgery within 4 weeks before screening that was assessed by the researcher as unsuitable for enrollment
- •Have malignant tumors within 5 years before enrollment, except tumors with negligible risk of metastasis or death and curable tumors, such as adequately treated cervical carcinoma in situ, cutaneous basal cell carcinoma, etc.
- •Have any of the following cardiovascular diseases: a.Left ventricular ejection fraction (LVEF) ≤45%, b. presence of active heart disease or congestive heart failure (New York Heart Association [NYHA] Class III or IV)), c.severe arrhythmias requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia), d.QTcB interval ≥450ms for men and ≥470ms for women, e.have myocardial infarction, bypass surgery, or stent placement within the 6 months before the study, f.other heart diseases judged by the researcher to be unsuitable for enrollment
- •Have a history of live attenuated vaccines within 6 weeks before enrollment
- •Participate in other interventional clinical studies during CNCT19 CAR T-Cell therapy, and the drug has a half-life of <
- •Subjects treated with active investigational drugs or intend to participate in another clinical trial or receive treatment other than that specified in the protocol throughout the study period
- •Have a history of epilepsy or other active central nervous system diseases
- •Have an allergy to the ingredients of the medicine used in this study
- •Previously received CAR-T cell therapy
- •Patients considered to be ineligible for the study by the investigator for reasons other than the above
研究组 & 干预措施
CNCT19 CAR T-Cell Therapy
Experimental
Participants will receive CNCT19 cell infusion after preconditioning, and they need to be closely monitored for 24 hours following CAR-T cell infusion. Participants are advised to remain in the hospital for a minimum of 14 days following cell infusion. The duration of hospitalization and observation will be determined based on the researcher's comprehensive assessment of the subject's condition.
干预措施: CNCT19 CAR-T cell therapy (Biological)
结局指标
主要结局
Incidence and the severity of the adverse event
时间窗: Within 12 months
Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess the adverse event
次要结局
- Percentage of patients with hematological response(Within 24 weeks)
研究者
研究点 (1)
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