NCT05828212已完成1 期
A Study on the Safety and Efficacy of Chimeric Antigen Receptor T Cells in the Treatment of Recurrent/Refractory Neuromyelitis Optica
Zhejiang University1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2023年5月15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
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Dose limited toxicity (DLT)
研究概览
简要总结
This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD19 CAR-T therapy for patients with relapsed or refractory Neuromyelitis Optica, and to evaluate the pharmacokinetics of CD19 CAR-T in patients.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 and gender unlimited;
- •NMOSD diagnosed based on the 2015 NMOSD International Consensus Diagnostic Criteria;
- •Diagnostic criteria for AQP4-IgG positive NMOSD Diagnostic criteria for AQP4-IgG positive NMOSD
- •At least 1 core clinical feature
- •Using reliable methods to detect positive AQP4-IgG (CBA method)
- •Exclude other diagnoses. Core clinical features
- •Acute myelitis
- •Posterior region syndrome, unexplained paroxysmal hiccup, nausea, and vomiting
- •Other brainstem syndromes
- •Symptomatic episodic sleeping sickness, diencephalic syndrome, brain MRI with NMOSD characteristic diencephalic lesions
- •Cerebral syndrome with NMOSD characteristic brain lesions
- •Corticosteroids combined with immunosuppressants (azathioprine or mycophenolate mofetil or rituximab) still relapse after treatment；
- •At least 2 relapses within the past 12 months or at least 3 relapses within the past 24 months, and at least 1 recurrence within the 12 months prior to screening；
- •The estimated survival time is more than 12 weeks;
- •Women of childbearing age who have negative urine pregnancy test before medication administration and agree to take effective contraceptive measures during the trial period until the last follow-up
排除标准
- •Epilepsy history or other central nervous system disease;
- •Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythm ia in the past;
- •Pregnant (or lactating) women;
- •Patients with severe active infections;
- •Active infection of hepatitis B virus or hepatitis C virus;
- •Systemic steroids have used in the 4 weeks before participating in the treatment (except recently or currently using inhaled steroids);
- •Those who have used any gene therapy products before;
- •The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- •Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
- •Those who suffer from other uncontrolled diseases are not suitable to join the study;
- •HIV infection;
- •Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
研究组 & 干预措施
Treatment Group
Experimental
Recurrent/Refractory Neuromyelitis Optica
干预措施: CAR-T cells injection (Drug)
结局指标
主要结局
Dose limited toxicity (DLT)
时间窗: From date of initial treatment to Day 28 post CAR-T infusion.
Dose limited toxicity
AE and SAE
时间窗: From admission to the end of the follow-up, up to 2 years
Adverse event and serious adverse event
Maximum tolerable dose
时间窗: From date of initial treatment to Day 28 post CAR-T infusion.
Maximum tolerable dose
次要结局
- Changes in serum AQP4-IgG titer after infusion(days 7, 14, 21, 28 and 90)
- Annual recurrence rate (ARR) of NMOSD(From admission to the end of the follow-up, up to 2 years)
- Changes in the expanded disability status scale (EDSS) score from baseline(days 7, 14, 21, 28 ,56 and 90)
- MRI active lesions(days 90)
- Changes in optimal corrected vision(days 28 and 90)
- Changes of nerve fiber layer around the retinal papilla(pRNFL)(2 years)
- Changes in the plexiform layer of macular ganglion cells (mGCIPL)(2 years)
研究者
He Huang
Clinical Professor
Zhejiang University
研究点 (1)
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