NCT06613490招募中早期 1 期
An Exploratory Clinical Study of the Safety and Efficacy of CD19 Chimeric Antigen Receptor NK Cells for the Treatment of Refractory Antisynthetase Antibody Syndrome and Rheumatoid Arthritis
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年5月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence of Dose-Limiting Toxicity (DLT)
研究概览
简要总结
A single-center, open-label dose-escalation design to evaluate the safety and efficacy of 3 infusions of anti CD19 CAR NK cells (KN5501), as well as the expansion and persistence of KN5501 in patients with refractory antisynthetase antibody syndrome (ASyS) and rheumatoid arthritis (RA); To evaluate the ability of KN5501 to clear CD19-positive B cells in patients to determine the feasibility of KN5501 for the treatment of refractory ASyS and or RA.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily sign the Informed Consent Form (ICF) , participate in this clinical study and be willing to follow and be able to complete all trial procedures.
- •Defined according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria, adult patients with RA diagnosed ≥3 months prior to screening;Moderately to severely active RA;Poor response, or loss of response, or intolerance to at least one conventional synthetic DMARD (csDMARD) or biologic DMARD (bDMARD) or targeted synthetic DMARD (tsDMARD).
- •Defined according to the 2020 ENMC-DM classification diagnostic criteria. Adult patients with ASyS diagnosed ≥3 months prior to screening; patients with moderately severe active ASyS.
- •Age: ≥ 18 years old and ≤ 70 years old, male or female.
- •Subjects with estimated survival > 12 weeks.
- •Serum creatinine clearance meets the relevant age/sex criteria, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN).
- •ECOG score 0 -
- •The heart structure is essentially normal by echocardiography and Left ventricular ejection fraction (LVEF) ≥45%.
- •2 weeks after the subject received the last dose treatment (hormonal, immunosuppressive or other experimental treatment).
排除标准
- •Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions.
- •Subjects with one of the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any of the known bone marrow failure syndromes.
- •Subjects with Active or uncontrolled infections requiring parenteral antimicrobials; evidence of severe active viral or bacterial infections or uncontrolled systemic fungal infections.
- •Subjects with grade III or IV heart failure (NYHA classification).
- •History of epilepsy or other central nervous system (CNS) diseases.
- •Subjects with history of malignancy except cured of carcinoma in situ of the skin or cervix, and patients with inactive tumors.
- •Subjects with pronounced bleeding tendencies, such as gastrointestinal bleeding, coagulation disorders, and hypersplenism.
- •The subject with unstable angina, symptomatic congestive heart failure or myocardial infarction within the last 6 months.
- •Females who are pregnant, lactating, or planning a pregnancy within six months.
- •Subjects who have received other clinical trial treatment within 3 months.
研究组 & 干预措施
anti CD19 CAR NK cells
Experimental
干预措施: anti CD19 CAR NK cells (Biological)
结局指标
主要结局
Incidence of Dose-Limiting Toxicity (DLT)
时间窗: up to 52 weeks after infusion
To characterize the safety of CD19 CAR NK Cells (KN5501) for refractory antisynthetase antibody syndrome (ASyS) and rheumatoid arthritis (RA)
Incidence of Treatment Emergent Adverse Events (TEAEs)
时间窗: up to 52 weeks after infusion
To characterize the safety of CD19 CAR NK Cells (KN5501) for refractory antisynthetase antibody syndrome (ASyS) and rheumatoid arthritis (RA)
次要结局
- The overall response rate (ORR)(4, 12, 24, 36 and 52 months after infusion)
研究者
Wenfeng Tan
Clinical Professor
The First Affiliated Hospital with Nanjing Medical University
研究点 (1)
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