Exploratory Clinical Study Initiated by Researchers on the Safety and Preliminary Efficacy of BGT007 in Treating Patients with Recurrent/refractory Gastrointestinal Malignancies
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 15
- 主要终点
- Dose-Limiting Toxicity (DLT)
研究概览
简要总结
This study is an exploratory research on single arm, open, and improved "3+3" dose escalation. BGT007 will explore two dose groups, namely (Group A: 3.0X10 ^ 8 3 cases, Group B: 6.0X10 ^ 8 3 cases), and receive the same dose infusion after observing lower adverse reactions and initial benefits (SD or PR), with an interval of one month. Each subject can receive a maximum of 3 infusions in total.
详细描述
Main research objectives:
Evaluate the safety and tolerability of BGT007 in treating patients with recurrent/refractory multiple gastrointestinal malignancies;
Secondary research objective:
- Evaluate the pharmacokinetic (PK) characteristics of BGT007;
- Evaluate the preliminary effectiveness of BGT007 product.
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
- 17 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1: Voluntarily sign a written informed consent form;
- •2: Age ≥ 18 years old and ≤ 75 years old, both male and female are acceptable;
- •3: Expected survival period ≥ 3 months;
- •4: The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) is 0 or 1;
- •5: Biopsy specimens or pathological paraffin sections (within 3 years prior to signing the informed consent form): target tests are both positive;
- •6: According to the RECIST v1.1 solid tumor evaluation criteria, there must be at least one measurable lesion, and the longest diameter evaluated by CT or MRI imaging in the baseline period must be ≥ 10 mm (excluding lymph nodes, whose short diameter must be ≥ 15 mm);
- •7: Advanced pancreatic cancer or colorectal cancer confirmed by histology or cytology, which has progressed through second-line or above standard treatment, or is intolerant of standard treatment, or has no standard treatment; Definition of intolerance: According to CTCAE V5.0, during the treatment process, there is a hematological toxicity of ≥ Grade IV, non hematological toxicity of ≥ Grade III, or damage to major organs such as the heart, liver, and kidneys of ≥ Grade II; The definition of treatment failure: disease progression (PD) during the treatment process or recurrence after treatment (including postoperative recurrence);
- •8: Can establish a single or intravenous blood collection pathway, and there are no other contraindications for blood cell isolation;
- •9: Having sufficient organ and bone marrow functions
- •10: Medical contraceptive measures. Female subjects of childbearing age must undergo a pregnancy test within 72 hours before the first administration, and the result must be negative.
排除标准
- •1: Active central nervous system metastases (excluding those that have been treated and stabilized);
- •2: HIV positive, HBsAg positive with HBV DNA copy number positive (greater than the detection limit), HCV antibody positive and HCV RNA positive, syphilis non-specific antibody (RPR or TRUST) positive;
- •3: Individuals with mental or psychological disorders who are unable to cooperate with treatment and efficacy evaluation;
- •4: Subjects with severe autoimmune diseases and long-term use of immunosuppressants;
- •5: Within the 14 days prior to enrollment, there were active or uncontrollable infections that required systemic treatment;
- •6: Any unstable systemic disease (including but not limited to): active infection (excluding local infection); Unstable angina pectoris; Cerebrovascular ischemia or cerebrovascular accident (within 6 months prior to screening); Myocardial infarction (within 6 months prior to screening); Congestive heart failure (NYHA classification ≥ III); Severe arrhythmia requiring medication treatment; Heart disease requiring treatment or uncontrolled hypertension after treatment (blood pressure>160mmHg/100 mmHg);
- •7: Functional impairment of important organs such as lungs, brain, and kidneys;
- •8: The subjects have undergone major surgery or severe trauma within 4 weeks prior to receiving treatment with the investigational product, or are expected to undergo major surgery during the study period;
- •9: Received any systemic chemotherapy, immunotherapy, or small molecule targeted therapy within 2 weeks prior to single collection or within 5 half lives (whichever is shorter);
- •10: Received treatment with chimeric antigen receptor modified T cells (including CAR-T and TCR-T) within six months;
- •11: Severe allergies or a history of allergies;
- •12: Subjects requiring anticoagulant therapy;
- •13: Pregnant or lactating women, or those with a pregnancy plan within six months (for both men and women)
- •14: Researchers believe that there are other reasons why treatment providers cannot be included.
研究组 & 干预措施
BGT007
Intravenous infusion
干预措施: Group A (Biological)
BGT007
Intravenous infusion
干预措施: Group B (Biological)
结局指标
主要结局
Dose-Limiting Toxicity (DLT)
时间窗: From the infusion (Day 0) to Day 28
DLT is defined as the following adverse events related to the investigational drug(definitely related, likely related,possibly related) that occur within 28 days after administration of BGT007 (using CTCAE 5.0 or CRS grading criteria): (1) hematological toxicity; (2) Grade 3 non hematological toxicity lasting for more than 7 days, or ≥ Grade 4 non hematological toxicity, regardless of duration, but excluding the following situations; (3)Cytokine Release Syndrome(CRS)
Maximum Tolerated Dose(MTD)
时间窗: From the infusion (Day 0) to Day 28
The highest dose of DLT observed in subjects with less than 2/6 (at least 6 subjects in this experimental group received BGT007 administration and completed DLT observation)
次要结局
未报告次要终点