计划状态
活跃，非招募阶段
第 1 阶段允许先接受免疫治疗
是CRC 指导的试验
是标签
MSI-H/ MMRd、MSS/ MMRp评论
Adoptive cells immunotherapy, targeted to KRAS G12D mutation.
Admits patients with Stage III or IV colon and/or rectal cancer, with KRAS G12D mutation and HLA-C*08:02 positive (both, MSS and MSI-H)
NT-112: Autologous, engineered T Cells targeting KRAS G12D
At least 1 line of prior treatment required, not prior adoptive cell and gene therapy allowed (not mention of prior checkpoint inhibitor being an exclusion criterion).
Patients receive a with fludarabine and cyclophosphamide, and late one unique infusion of T cell receptor (TCR) T cells. After that, other immunotherapy, recombinant interleukin-2 (rIL-2).
| 地点 | 位置状态 |
|---|---|
| 美国 | |
|
研究网站 加利福尼亚州杜阿尔特 91010 |
活跃，非招募 |
|
研究网站 加利福尼亚州洛杉矶 90095 |
活跃，非招募 |
|
研究网站 加利福尼亚州纽波特海滩 92663 |
活跃，非招募 |
|
研究网站 堪萨斯州韦斯特伍德 66205 |
活跃，非招募 |
|
研究网站 密苏里州圣路易斯 63110 |
活跃，非招募 |
|
研究网站 纽约州纽约市 10016 |
活跃，非招募 |
|
研究网站 Pittsburgh, Pennsylvania 15237 |
活跃，非招募 |
|
研究网站 田纳西州纳什维尔 37203 |
活跃，非招募 |
|
研究网站 德克萨斯州达拉斯 75246 |
活跃，非招募 |
|
研究网站 Galveston, Texas 77555 |
活跃，非招募 |
|
研究网站 德克萨斯州休斯顿 77030 |
活跃，非招募 |
|
研究网站 Aberdeen, Washington 98520 |
活跃，非招募 |
|
研究网站 威斯康星州密尔沃基 53226 |
活跃，非招募 |
纳入标准
主要纳入标准：
* Age ≥18 years
* Diagnosed with NSCLC, Colorectal adenocarcinoma, Pancreatic adenocarcinoma, Endometrial Cancer or any other solid tumor
* Tumors must harbor a KRAS G12D variant mutation and subject must be HLA-C*08:02 positive
* Subject has advanced solid cancer, defined as unresectable, advanced, and/or metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.
* Presence of at least 1 measurable lesion per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment
钥匙
排除标准
排除标准：
* Any other primary malignancy within the 3 years prior to enrollment (except for non-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or low-grade prostate cancer
* Known, active primary central nervous system (CNS) malignancy
* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.
* History of stroke or transient ischemic attack within the 12 months prior to enrollment.
* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.
* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.
* Any form of primary immunodeficiency.
* Active immune-mediated disease requiring systemic steroids or other immunosuppressive treatment (except if related to prior checkpoint inhibitor therapy)
* Female of childbearing potential who is lactating or breast feeding at the time of enrollment
