计划状态
暂停阶段
第 1 阶段允许先接受免疫治疗
是CRC 指导的试验
是药物
IL-2, NeoTCR-P1 adoptive cell therapy, Nivolumab标签
MSS/ MMRp评论
Adoptive cells transfer (TCR) with/without checkpoint inhibitor (anti PD-1)
[*similar* concept that TCR trial at NIH (NCT03412877)]
NeoTCR-P1 adoptive cell therapy
nivolumab (Opdivo, anti PD-1)
NeoTCR P1 is an autologous adoptive T cell therapy (ACT) for patients with solid cancer.
“Upon reinfusion of a defined dose into the patient, NeoTCR-P1 cells are anticipated to traffic to tissues harboring tumor cells presenting the neoE peptide in the context of the autologous cognate HLA receptor. Recognition of the cognate neoE-HLA complexes will trigger Tcell proliferation and secretion of effector molecules from the engineered Tcells.”
Key inclusion/exclusion criteria.
– Disease has progressed after at least one available standard therapy or no additional curative therapies are available
- 可测量的疾病
– Prior chimeric antigen receptor therapy or other genetically modified T cell therapy (that means that prior checkpoint inhibitor is allowed)
| 地点 | 位置状态 |
|---|---|
| 美国 | |
|
希望之城 加利福尼亚州杜阿尔特 91010 |
暂停 |
|
University of California, Los Angeles 加利福尼亚州洛杉矶 90024 |
暂停 |
|
University of California, Irvine Medical Center 加利福尼亚州奥兰治 92868 |
暂停 |
|
University of California, Davis 加利福尼亚州萨克拉门托 95817 |
暂停 |
|
University of California, San Francisco 加利福尼亚州旧金山 94158 |
暂停 |
|
Northwestern University Medical Center 伊利诺伊州芝加哥 60611 |
暂停 |
|
纪念斯隆-凯特琳癌症中心 纽约州纽约市 10065 |
暂停 |
|
Tennessee Oncology 田纳西州纳什维尔 37203 |
暂停 |
|
弗雷德-哈钦森癌症研究中心 华盛顿州西雅图 98109 |
暂停 |
纳入标准
纳入标准
Histologically or cytologically documented incurable or metastatic solid tumors of the following types: melanoma, UC, ovarian cancer, colorectal cancer, breast cancer (HR+), or prostate cancer.
Disease has progressed after at least one available standard therapy or no additional curative therapies are available.
Measurable disease per RECIST v1.1
Eastern cooperative oncology group (ECOG) performance status of 0 or 1
Adequate hematologic and end organ function determined within 30 days prior to enrollment.
Disease-specific criteria related to the specific tumor type are required.
Note: There are additional inclusion criteria. The study center will determine if you meet all of the criteria.
排除标准
排除标准：
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and/or inherited liver disease
Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases
Uncontrolled or symptomatic hypercalcemia
Pregnancy, lactation, or breastfeeding
Prior allogeneic stem cell transplant or solid organ transplant
Prior chimeric antigen receptor therapy or other genetically modified T cell therapy
Active HIV, Hepatitis B, or Hepatitis C infection
Active tuberculosis
Severe infection within 2 weeks prior to enrollment
Major surgical procedure within 4 weeks prior to enrollment or anticipation of need for a major surgical procedure during the study.
Note: There are additional exclusion criteria. The study center will determine if you meet all of the criteria.
