NCT01837602已完成1 期
Clinical Trial of Autologous cMet Redirected T Cells Administered Intratumorally in Patients With Breast Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Number of Serious Adverse Event
研究概览
简要总结
An open-label, clinical trial of autologous cMet redirected T cells administered intratumorally (IT) in patients with breast cancer. Fifteen evaluable patients will be enrolled in stepwise fashion. Step 1 will enroll patients with metastatic breast cancer refractory to at least 1 standard therapy, step 2 will include newly diagnosed patients with operable triple negative breast cancer.
详细描述
This study is designed to determine the safety and feasibility of intratumoral administration of autologous T cells that have had genetic material transferred into the cell to redirect them to target breast cancer cells rather than their usual target. Eligible subjects will have metastatic breast cancer refractory to at least one standard therapy or to newly diagnosed with operable triple negative breast cancer.
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
- •Step 1 subjects only: metastatic breast cancer patients with an accessible tumor (cutaneous, subcutaneous, or superficial) and/or palpable adenopathy/mass. The targeted tumor is accessible (i.e. is not near a great vessel or the spinal cord) and can be surgically excised or biopsied.
- •Step 2 subjects only: Newly diagnosed, operable, triple negative breast cancer, i.e. ER/PR-negative, her2/neu-negative, with tumor size between 2 - 3 cm (T2) as measured by either clinical breast exam, mammogram, ultrasound or MRI, with or without ipsilateral axilla node involvement (N0 or N1).
- •cMet expression in ≥ 30% tumor cells as demonstrated on immuno-histochemistry analysis of archival slides. The intensity for cMet IHC should be greater than or equal to 1+. Punch biopsy or percutaneous core biopsy may be offered to Cohort 1 patients. To establish eligibility for patients in step 1, archival tumor tissues from any previously biopsied metastatic tumor deposit may be used for IHC staining. The metastatic tumor nodule to be targeted for IT injection may not necessarily be the same as previously biopsied metastatic site.
- •Age > 18 years old
- •Baseline Eastern Cooperative Oncology Group (ECOG) Clinical Performance Status 0 or 1
- •Adequate hematologic function:
- •WBC > 3.0 Plt > 75,000 Hgb > 10 g/dl Adequate renal function defined as serum creatinine < 1.5 times upper limit of normal
- •Adequate hepatic function defined as: Total bilirubin < 1.5 times upper limit of normal, and ALT and AST < 2.5 times upper limit of normal
- •Women of child bearing potential must have a negative pregnancy test (blood or urine) and agree to use appropriate contraception from study screen through the duration of the trial. Men must agree to use appropriate contraception from IT injection through the duration of the trial.
- •Signed and dated written informed consent.
排除标准
- •Step 1 subjects only: Targeted tumor near a great vessel or spinal cord
- •Step 2 subjects only: Women already undergoing neoadjuvant chemotherapy to treat their primary triple negative breast cancer
- •Step 1 and 2 subjects:Positive for HIV-1/HIV-2
- •Active hepatitis B or hepatitis C infection
- •The anticipated use of the following within 2 weeks prior to apheresis and prior to planned IT T-cell injection:
- •Immunosuppressive drugs Cytotoxic chemotherapy (See Section 5.7 for complete details) Systemic glucocorticoids (steroid prep due to dye allergies prior to staging scans or use in anti-emetic prophylaxis for patients undergoing chemotherapy is allowed) Hematopoietic growth factors Other experimental therapy Note: Step 1 patients receiving non-investigational targeted therapy (lapatinib, trastuzumab, and/or pertuzumab) are eligible provided these medicines are at a stable dose and the patient began taking them more than 30 days prior to the planned IT T-cell injection.
- •Anticipated use of anti-coagulants such as coumadin, heparin, or Lovenox within 14 days before the planned IT T-cell injection RETIRED AS OF PROTOCOL VERSION 11
- •Pregnant women or nursing mothers
- •History of alcohol abuse or illicit drug use within 12 months of IT T-cell injection
- •Clinically significant comorbid disease or other underlying condition, including major autoimmune disorders that would contraindicate study therapy or confuse interpretation of study results
- •Significant psychiatric disorder and any other reason that in the Investigator's opinion would jeopardize protocol compliance or compromise the patient's ability to give informed consent.
- •Prior MI ascertained from medical history and review of systems
结局指标
主要结局
Number of Serious Adverse Event
时间窗: Two years
次要结局
未报告次要终点
研究者
研究点 (2)
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