NCT07496073尚未招募1 期
A Phase I, Single-arm, Open-label Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of CHT101 Cell Infusion in Adult Subjects With Recurrent or Progressive Malignant Primary Brain Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Safety and Tolerability
研究概览
简要总结
Recurrent or progressive primary malignant brain tumors are among the malignancies with a poor prognosis. They refer to primary brain tumors that either recur after standard treatment or show disease progression during the course of standard therapy. This group includes a variety of histological types, most commonly glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, and primary central nervous system lymphoma.
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
- •Tumor tissue specimens must be CD70-positive as determined by immunohistochemistry (IHC).
- •Subjects must be pathologically confirmed to have high-grade glioma, defined as WHO (2021) Central Nervous System Tumor Classification grade 3 or 4 gliomas; or primary central nervous system lymphoma (PCNSL).
- •Contrast-enhanced magnetic resonance imaging (MRI) must demonstrate the presence of an intracranial space-occupying lesion, with at least one measurable lesion.
- •At the time of signing the informed consent form (ICF), the Karnofsky Performance Status (KPS) score must be ≥70.
排除标准
- •Patients with brainstem recurrence, spinal dissemination, or extracranial metastasis.
- •History of bone marrow or solid organ transplantation. History of other primary malignancies within 5 years prior to study treatment. Prior receipt of CD70-targeted antitumor therapies, including but not limited to CD70-targeted cell therapies (autologous or allogeneic) and TCR-T therapy.
- •Prior treatment with CAR-T therapy or other cell/gene therapies. Presence of acute or moderate-to-severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to signing the informed consent form (ICF), or receipt of systemic therapy for GVHD within 4 weeks prior to the first infusion.
- •Clinically significant cardiovascular disease. Epilepsy that is difficult to control with medication, or chronic symptoms and signs of intracranial hypertension.
- •Inadequate bone marrow reserve or organ function. Pregnant or breastfeeding female subjects.
结局指标
主要结局
Safety and Tolerability
时间窗: 2 years
Treatment-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events
次要结局
- Objective response rate (ORR)(2 years)
- Progress-free survival(PFS)(2 years)
- Overall survival (OS )(2 years)
- pharmacokinetics (PK)(2 years)
- Pharmacodynamics (PD)(2 years)
研究者
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