Clinical Study of UTAA07 Injection in the Treatment of CD7 Positive Adult Relapsed/Refractory Hematologic and Lymphatic Systemic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This is a single-arm, open-label study designed to evaluate the safety, tolerability and cellular pharmacokinetic profiles of UTAA07 Injection. It also aims to preliminarily assess the efficacy of the investigational drug in subjects with relapsed/refractory hematolymphoid malignancies, so as to identify the optimal dose for subsequent formal clinical trials.
详细描述
This is a single-arm, open-label study designed to investigate the safety, tolerability, and cellular kinetic characteristics of the investigational product. Additionally, it aims to preliminarily observe the efficacy of the investigational product in subjects with relapsed/refractory hematological and lymphoid malignancies, so as to explore the optimal dose for formal clinical applications.
Three dose cohorts are planned, namely 2×10⁹ CAR-γδT cells, 4×10⁹ CAR-γδT cells, and 6×10⁹ CAR-γδT cells. Additional dose cohorts may be added at the discretion of the investigator and/or collaborating institutions. The study will adopt a 3+3 dose escalation/de-escalation schema.
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
- •Aged ≥ 18 years, regardless of gender.
- •Expected survival time ≥ 3 months.
- •ECOG performance status score of 0-
- •Confirmed diagnosis of relapsed/refractory CD7-positive hematolymphoid malignancies at screening.
- •Coagulation function, liver and kidney function, and cardiopulmonary function meeting the requirements.
- •Ability to understand the trial and signed informed consent form.
排除标准
- •A history of malignant tumors other than hematolymphoid malignancies within 5 years prior to screening, excluding carcinoma in situ.
- •Positive results for virological tests or syphilis.
- •Severe cardiac diseases.
- •Unstable systemic diseases as determined by the investigator.
- •Active or uncontrolled infections requiring systemic treatment within 7 days prior to screening, excluding mild urinary and reproductive system infections and upper respiratory tract infections.
- •Pregnant or lactating women; female subjects planning to become pregnant within 2 years after cell infusion; or male subjects whose partners plan to become pregnant within 2 years after the subject's cell infusion.
- •Subjects receiving systemic corticosteroid therapy within 7 days prior to screening, or those judged by the investigator to require long-term systemic corticosteroid therapy during the trial period, excluding inhaled or topical administration.
- •Participation in other clinical studies within 1 month prior to screening.
- •Evidence of central nervous system (CNS) involvement at screening, such as detection of tumor cells in cerebrospinal fluid (CSF) or imaging findings suggestive of CNS infiltration.
- •Patients requiring long-term use of immunosuppressants as determined by the investigator at screening.
- •A history of epilepsy or other central nervous system diseases.
- •Patients with primary immunodeficiency diseases.
- •Other circumstances deemed inappropriate for enrollment by the investigator.
研究组 & 干预措施
UTAA07 injection
干预措施: CAR-T cell infusion (Drug)
UTAA07 injection
干预措施: UTAA07 injection (Drug)
结局指标
主要结局
Adverse Events
时间窗: 24 months
Types, frequencies, and severity of adverse events (AEs) and laboratory abnormalities (in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0)
次要结局
未报告次要终点