Safety, Tolerability and Preliminary Efficacy of Erythrocyte-αPD-1 Conjugate Injection in Patients With Advanced Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 39
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This is an investigator-initiated, multi-center, open-label clinical study to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of Erythrocyte-αPD-1 conjugates in patients with advanced malignancies
详细描述
This is an investigator-initiated, multi-center, open-label clinical study to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of Erythrocyte-αPD-1 conjugates in patients with unresectable or metastatic advanced malignancies who have failed previous systemic therapy.
The study was divided into two phases: dose escalation and dose expansion
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject signs an informed consent form, understands this study, is willing to follow and has the ability to complete all experimental procedures;
- •Regardless of gender, aged 18 to 75 years old (including threshold);
- •Patients with advanced malignant tumors who have been confirmed by histopathology;
- •Patients with histopathologically confirmed unresectable or metastatic solid tumors who have failed systemic treatment or have no effective standard treatment, or who are unwilling to accept standard treatment or are not suitable for standard treatment;
- •Expected life ≥ 3 months；
- •Male participants, their spouses, and female participants of childbearing age should agree to use a medically recognized effective contraceptive method from the signing of the informed consent form until 3 months after the last administration; Pregnancy testing results for women of childbearing age within ≤ 7 days before the first trial drug administration must be negative. Women of childbearing age include premenopausal women and women within 2 years after menopause.
排除标准
- •People with other serious medical diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, active bleeding, etc., and people with uncontrollable or serious cardiovascular diseases,
- •Patients with clinical symptoms and the need for repeated drainage of pleural and ascitic fluids;
- •Previous or recent history of pulmonary fibrosis, severe lung function damage caused by pneumoconiosis, radiation pneumonia, and drug-related pneumonia;
- •There have been adverse events related to the use of IO drugs that require permanent cessation of IO treatment;
- •Known to have other malignant tumors, currently progressing or completing treatment at least once in the past 3 years.
- •Subjects with symptomatic central nervous system (CNS) metastasis confirmed by imaging or pathological examination and clinically unstable for at least 14 days prior to enrollment who require steroid treatment;
- •Having hereditary bleeding tendencies or coagulation disorders, or a history of thrombosis, hemolysis, or hemorrhagic diseases; Received significant surgical treatment or obvious traumatic injury within 28 days prior to the start of research treatment
研究组 & 干预措施
Dose Escalation
Dose Escalation of Erythrocyte-αPD-1 conjugate monotherapy in patients with advanced malignancy
干预措施: Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes (Drug)
Dose Expansion
Dose Expansion of Erythrocyte-αPD-1 conjugate monotherapy in patients with advanced malignancy
干预措施: Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: through study completion, an average of 1 year
The incidence of adverse events (AE), treatment related adverse events (TRAE), and severe adverse events (SAE) during the treatment of engineered erythrocytes
次要结局
- Efficacy of Erythrocyte-αPD-1 Conjugate(per 6 weeks)
- Pharmacodynamics characteristics Area under the plasma concentration versus time curve（AUC）(through study completion, an average of 1 year)
- Pharmacodynamics characteristics Peak Plasma Concentration(Cmax)(through study completion, an average of 1 year)