NCT04137536进行中（未招募）1 期
Phase Ib Treatment of Advanced Pancreatic Cancer With Anti-CD3 x Anti-EGFR-Bispecific Antibody Armed Activated T-Cells (BATs)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 7
- 试验地点
- 3
- 主要终点
- Evaluate toxicity
研究概览
简要总结
The purpose of this study is to find the safest dose and identify any bad side effects of EGFR-BATs (bispecific antibody-armed activated T cells) for people with advanced pancreatic cancer who have already received first-line standard chemotherapy.
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
- •* Histological or cytological proof of pancreatic adenocarcinoma. Must have metastatic pancreatic cancer who have received at least first line chemotherapy. Disease stability or progression during or within 6 months after treatment with 5-Fluorouracil (5-FU)- or gemcitabine-based chemotherapy. KPS\>/= 70% or SWOG performance Status 0 or 1
- •* Evaluable disease by iRECIST criteria
- •* Absolute Neutrophil Count (ANC) \>/= 1,000/mm\^3
- •* Lymphocyte count \>/= 400/mm\^3
- •* Platelet Count \>/= 75,000/mm\^3
- •* Hemoglobin \>/= 8 g/dL
- •* Serum Creatinine \< 2.0 mg/dl, Creatinine Clearance \>/=50 ml/mm (can be calculated or measured)
- •* Total Bilirubin \/= 55% at rest (\/= 18 years at the time of consent (Written informed consent and HIPAA authorization for release of personal health information)
- •* Females of childbearing potential, and males, must be willing to use an effective method of contraception
- •* Females of childbearing potential must have a negative pregnancy test within 7 days of being registered for protocol therapy
排除标准
- •Any chemotherapy related toxicities from prior treatment, > grade 2 per CTCAE v4.0
- •Known hypersensitivity to cetuximab or other EGFR antibody
- •Treatment with any investigational agent within 14 days prior to being registered for protocol therapy
- •Symptomatic brain metastasis
- •Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Steroid premedication for imaging scans is allowed. Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- •Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to being registered for protocol therapy
- •Active liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- •Known HIV infection
- •Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed)
- •Has an active infection requiring systemic therapy
- •A serious uncontrolled medical disorder that in the opinion of the Investigator may be jeopardized by the treatment with protocol therapy.
- •Females must not be breastfeeding
- •Patient may be excluded if, in the opinion of the PI and investigator team, the patient is not capable of being compliant
研究组 & 干预措施
Pancreatic Adenocarcinoma
Experimental
Participants have metastatic pancreatic cancer who have received at least first line chemotherapy and have disease progression during or within 6 months of treatment.
干预措施: anti-EGFR-bispecific antibody armed activated T-cells (Drug)
结局指标
主要结局
Evaluate toxicity
时间窗: 1 year
The NCI CTEP CTCAE v4.0 will be used.
次要结局
未报告次要终点
研究者
研究点 (3)
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