NCT05722171Unknown早期 1 期
Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute
PersonGen BioTherapeutics (Suzhou) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年12月27日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Assessment of the safety after UTAA06 injection treatment (Safety)
研究概览
简要总结
This is a single-arm, open-label, dose-escalation study to explore the safety, efficacy, and cytodynamic characteristics of the drug, and to initially observe the efficacy of the drug in subjects with relapsed/refractory B7-H3-positive acute myeloid cell line leukemia.
详细描述
Eligible subjects will receive 1.0×10^8 CAR gdT, 2.0×10^8 CAR gdT, 4.0×10^8 CAR gdT, or additional doses may be added at the discretion of investigator and sponsor.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Age≥ 18 years old, gender is not limited;
- •(2) expected survival time≥ 3 months;
- •(3) ECOG score 0-1 points;
- •(4) Acute myeloid leukemia was clearly diagnosed during screening, and tumor cells were positive for B7-H3 expression;
- •(5) Subjects with relapsed/refractory acute myeloid leukemia who have failed standard treatment or lack effective treatment methods.
- •(6) Coagulation function, liver and kidney function, cardiopulmonary function meet requirements.
- •(7) Be able to understand the trial and have signed the informed consent form.
排除标准
- •(1) Malignant tumors other than acute myeloid leukemia within 5 years before screening;
- •(2) Those who test positive for virus and syphilis;
- •(3) Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association [NYHA] classification≥ grade III), severe arrhythmia;
- •(4) Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
- •(5) Active infection or uncontrollable infection requiring systemic treatment within 7 days prior to screening;
- •(6) pregnant or lactating women, female subjects who planned to become pregnant within 2 years after cell reinfusion or male subjects whose partners planned to become pregnant within 2 years after their cell reinfusion;
- •(7) Subjects who were receiving systemic steroid therapy within 7 days prior to the year or who were judged by the investigator to require long-term systemic steroid therapy during treatment (other than inhalation or topical use);
- •(8) Have participated in other clinical studies within 1 month before screening;
- •(9) There was evidence of central nervous system invasion during subject screening, such as tumor cells detected in cerebrospinal fluid or imaging showing central infiltration;
- •(10) Those who have graft-versus-host response and need to use immunosuppressants;
- •(11) Those with a history of epilepsy or other central nervous system diseases;
- •(12) Patients with primary immunodeficiency diseases;
- •(13) situations that other investigators consider unsuitable for enrollment.
结局指标
主要结局
Assessment of the safety after UTAA06 injection treatment (Safety)
时间窗: About 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
次要结局
- To evaluate anti-tumor activity (overall survival)(About 2 years)
- To evaluate anti-tumor activity (duration of response)(About 2 years)
- To evaluate anti-tumor activity (progression free survival)(About 2 years)
研究者
研究点 (1)
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