Tumor-Associated Antigen (TAA) Specific Cytotoxic T Lymphocytes Administered in Patients With Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 3
- 主要终点
- Number of Patients Who Received 6 Infusions of multiTAA-specific T Cells
研究概览
简要总结
Status - CLOSED TO PATIENT ENROLLMENT (CNPE)
Patients who have pancreatic cancer that has come back or has not gone away after treatment, including the standard treatment for this disease or patients who are not eligible for or have elected not to receive standard of care chemotherapy, and patients who will have surgery after treatment for pancreatic cancer are eligible for this study. This is a research study using special immune system cells called tumor-associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy.
The proteins that are targeted in this study are called tumor-associated antigens (TAAs). These are cell proteins that are specific to the cancer cell. They do not show, or they show up in low quantities, on normal human cells. In this study, five common TAAs will be targeted. They are called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX2. On a different study, patients have been treated and so far this treatment has shown to be safe.
Investigators now want to try this treatment in patients with pancreatic cancer.
These TAA-specific cytotoxic T lymphocytes (TAA-CTLs) are an investigational product not approved by the Food and Drug Administration.
*Arm A and Arm B are closed to new patient enrollment.*
详细描述
Status - CLOSED TO PATIENT ENROLLMENT (CNPE)
The patient will give blood to make TAA-Specific cytotoxic T cells in a lab. These cells well be grown and frozen. If the TAA-Specific cytotoxic T cells can be made, the time from collection of the blood to manufacture of T cells for administration to the patient is about 1 to 2 months.
The cells will be infused by intravenous infusion (IV) into the patient over 1-10 minutes. The patient may be pre-treated with acetaminophen (Tylenol) and diphenhydramine (Benadryl). Acetaminophen (Tylenol) and diphenhydramine (Benadryl) are given to prevent a possible allergic reaction to the TAA-CTL administration.
Patients will be given up to six doses of TAA-CTLs at monthly intervals. The treatments will be given by the Center for Cell and Gene Therapy at Houston Methodist Hospital (HMH).
MEDICAL TESTS BEFORE TREATMENT:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •PROCUREMENT:
- •Any patient with biopsy proven pancreatic adenocarcinoma.
- •Patients with life expectancy greater than or equal to 6 months.
- •Age greater than or equal to 18 years
- •Hgb greater than or equal to 7.0 g/dl (transfusions allowed)
- •Any patient with biopsy-proven pancreatic adenocarcinoma:
- •Group A: Patients with locally advanced or metastatic adenocarcinoma who are responding (defined as stable disease or tumor volume reduction) following 3 cycles of first line chemotherapy
- •Group B: Patients with locally advanced or metastatic adenocarcinoma who have failed first line chemotherapy or are intolerant, ineligible or unwilling to receive standard of care chemotherapy
- •Group C: Patients with resectable pancreatic cancer who have completed planned neo-adjuvant chemotherapy, radiotherapy or combination
- •Patients must have measurable or evaluable disease per RECIST 1.1 criteria.
- •Patients with life expectancy greater than or equal to 12 weeks
- •Age greater than or equal to 18
- •Pulse oximetry of greater than 95 percent on room air in patients who previously received radiation therapy
- •Patients with an ECOG score of ≤ 2 or Karnofsky score of 50 or greater
- •Patients with bilirubin less than or equal to 2x upper limit of normal, AST less than or equal to 3x upper limit of normal, Hgb greater than or equal to 7.0 g/dl (transfusion allowed).
- •Patients with a creatinine less than or equal to 2x upper limit of normal for age
- •Patients should have been off other investigational therapy for one month prior to receiving treatment on this study.
- •For Groups B or C patients must be off conventional therapy for at least 1 week prior to receiving treatment on this study.
- •Informed Consent explained to, understood by and signed by patient. Patient given copy of informed consent.
- •Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom. Females of child-bearing potential must be willing to utilize one of the more effective birth control methods during the study unless female has had a hysterectomy or tubal ligation.
排除标准
- •PROCUREMENT:
- •Patients with severe intercurrent infection.
- •Patients with active HIV infection (can be pending at this time)
- •Patients with severe intercurrent infection.
- •Patients receiving systemic corticosteroids (Patients off steroids for at least 48 hours are eligible)
- •HIV positive
研究组 & 干预措施
Group A (Closed to New Patient Enrollment)
Patients with locally advanced or metastatic pancreatic adenocarcinoma who are responding following 3 cycles of first line chemotherapy will receive 6 infusions with a fixed dose of multiTAA specific T cells beginning on the 4th week of the 4th cycle of chemotherapy. MultiTAA T cell infusions will occur on day 21 (a chemotherapy "off" week) of each chemotherapy cycle starting on chemotherapy cycle 4.
干预措施: multiTAA specific T cells (Biological)
Group B (Closed to New Patient Enrollment)
Patients with locally advanced or metastatic pancreatic adenocarcinoma who have failed first line chemotherapy or are intolerant or ineligible to receive standard of care chemotherapy will be evaluated in the clinic and receive 6 infusions (administered at monthly intervals) with a fixed dose of multiTAA specific T cells.
干预措施: multiTAA specific T cells (Biological)
Group C (Closed to New Patient Enrollment)
Patients with resectable pancreatic adenocarcinoma following completion of neoadjuvant chemotherapy, radiotherapy or combination. These patients will receive 6 infusions with a fixed dose of multiTAA specific T cells. One infusion will occur 4 weeks prior to surgical resection (with an option to infuse up to one week earlier) and after the completion of all pre-operative chemotherapy and/or radiation. The subsequent 5 infusions will occur at monthly intervals beginning 8 weeks post-surgery. Following surgery all patients will additionally receive 3 months of standard of care (SOC) chemotherapy starting week 9 after surgery. Hence, SOC chemo will occur weeks 9-11, 13-15, and 17-19 post-surgery and multiTAA T cell infusions will occur at weeks 8, 12, 16, 20, and 24 post-surgery.
干预措施: multiTAA specific T cells (Biological)
结局指标
主要结局
Number of Patients Who Received 6 Infusions of multiTAA-specific T Cells
时间窗: 6 months
To determine the feasibility of completing a total of 6 intravenous infusions of multiTAA-specific T cells to pancreatic cancer patients with metastatic, locally advanced unresectable, or resectable disease
Number of Patients With Treatment Related Serious Adverse Events
时间窗: 7 months
To determine the safety of up to 6 intravenous infusions of multiTAA-specific T cells in pancreatic cancer patients with metastatic, locally advanced unresectable, or resectable disease.
次要结局
- Progression Free Survival Using the Kaplan-Meier Method(5 years)
- Overall Survival Using the Kaplan-Meier Method(5 years)
研究者
Benjamin Leon Musher
Assistant Professor
Baylor College of Medicine