计划状态
招聘阶段
第 1 阶段 第二阶段允许先接受免疫治疗
是CRC 指导的试验
是药物
AFNT-211标签
MSI-H/ MMRd、MSS/ MMRp评论
Targeted immunotherapy-only trial that admits patients with advanced/ metastatic colorectal cancer with a KRAS G12V mutation. For both, MSS and MSI-H patients.
Trial with engineered TCR T-cells.
AFNT-211: cellular therapy; autologous CD4+ and CD8+ T cells engineered to express a HLA-A*11:01-restricted KRAS G12V-specific transgenic T cell receptor (TCR), the wildtype CD8α/β coreceptor, and a FAS-41BB switch receptor (see Helpful Links for Publications).
Prior immunotherapy allowed, as well as other therapies, after a 14 days wash-out period.
No need to exhaust standard of care: patients are allowed if they progressed on or are intolerant of at least one prior line of standard systemic
| 地点 | 位置状态 |
|---|---|
| 美国 | |
|
USC Norris Comprehensive 加利福尼亚州洛杉矶 90033 |
招聘 |
|
University of California Los Angeles Department of Medicine 加利福尼亚州洛杉矶 90095 |
招聘 |
|
University of California San Francisco San Francisco, California 94143 |
招聘 |
|
Yale New Haven Hospital New Haven, Connecticut 06511 |
招聘 |
|
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health 纽约州纽约市 10016 |
招聘 |
|
纪念斯隆-凯特琳癌症中心 纽约州纽约市 10065 |
招聘 |
|
Providence Cancer Institute Franz Clinic 俄勒冈州波特兰 97213 |
招聘 |
|
萨拉-坎农研究所 田纳西州纳什维尔 37203 |
招聘 |
|
MD 安德森癌症中心 德克萨斯州休斯顿 77030 |
招聘 |
|
Fred Hutchinson Cancer Center 华盛顿州西雅图 98109 |
招聘 |
|
University of Wisconsin Carbone Cancer Center 威斯康星州麦迪逊 53792 |
招聘 |
联系方式
纳入标准
主要纳入标准：
1. Confirmed KRAS G12V mutational status and HLA-A*11:01 allele
2. Histologically confirmed advanced or metastatic, unresectable solid tumor
3. Progressed on or intolerant of at least one prior line of standard systemic therapy for the current malignancy.
4. Measurable disease per RECIST v1.1.
5. ECOG performance status 0-1
6.适当的器官和骨髓功能
钥匙
排除标准
排除标准：
1. Any systemic cytotoxic chemotherapy, investigational agents, or any anti-tumor drug from a previous treatment regimen or clinical study (including small molecules and I/O compounds) within 5 half-lives or 14 days of Screening, whichever is shorter.
2. Any prior gene therapy utilizing an integrating vector
3. Previous allogeneic stem cell transplantation or prior organ transplantation
4. History of treated primary immunodeficiency, autoimmune, or inflammatory disease including inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis, or Grave's disease
5. Primary brain tumor
6. Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression.
7. Uncontrolled active bacterial, viral, fungal, or mycobacterial infection
8. Pregnant or lactating subjects
9. Surgery or catheter-based interventions
10. Previously identified allergy, hypersensitivity, or known contraindication to cyclophosphamide, fludarabine, or any other agent associated with lymphodepleting chemotherapy (LDC) or AFNT-211 product
11. Uncontrolled significant intercurrent or recent illness
12. Diagnosis of another malignancy within 2 years prior to screening.
13. Seropositive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb)
14. Seropositive for hepatitis C antibody.
15. Known human immunodeficiency virus (HIV) infection
