Ignite Creation Date:
2024-05-06 @ 1:07 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03932565
Status:
UNKNOWN
Last Update Posted:
2020-11-18
First Post:
2019-04-27
Brief Title:
Interventional Therapy Sequential With the Fourth-generation CAR-T Targeting Nectin4FAP for Malignant Solid Tumors
Sponsor:
The Sixth Affiliated Hospital of Wenzhou Medical University
Organization:
The Sixth Affiliated Hospital of Wenzhou Medical University
Study Overview
Official Title:
Clinical Trial Study of Interventional Therapy Sequential With the Fourth-generation CAR-T Cells IL7 and CCL19 or and IL12 Targeting Nectin4FAP in the Treatment of Advanced Malignant Solid Tumors With Nectin4-positive
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
According to the high expression of tumor cell-associated antigen Nectin4 in patients with solid tumors such as non-small cell lung cancer breast cancer ovarian cancer bladder cancer and pancreatic cancer and in order to target FAP-positive CAFs in the tumor-associated stroma the Intravenous minimally invasive surgery combined with intratumoral injection of Nectin4FAP-targeted fourth-generation CAR-T cells expressing IL7 and CCL19 or IL12 are used to treat Nectin4-positive advanced malignant solid tumors maximally eliminating residual cancer cells and preventing recurrence
Detailed Description:
Currently malignant tumors are the leading cause of death Surgery chemotherapy radiation therapy and targeted therapy have become the four foundations of cancer treatment for many years With the development of science and technology immunotherapy has become the fifth pillar of cancer treatment The most hot topic in immunotherapy is CAR-T therapy The basic principle of CAR-T therapy chimeric antigen receptor-T cells is mainly to use the patients own immune cells to clear cancer cells CAR is a core component of CAR-T conferring T cell a HLA-independent way to recognize tumor antigens allowing CAR-modified T cells to recognize a broader target than the natural T cell surface receptor TCR The basic design of CAR includes a tumor associated antigen TAA binding region an extracellular hinge region a transmembrane region and an intracellular signaling region The selection of target antigens is a key determinant of the specificity and effectiveness of CAR and the safety of genetically modified T cells themselves
Nectin-4 is a type I transmembrane protein whose extracellular domain is composed of three Ig-like domains V-C-C type which together with cadherin participate in the formation and maintenance of adhesion junctions Nectin-4 is ubiquitously expressed in human embryonic cells but is hardly expressed in normal adult tissues Nectin-4 is highly expressed on the surface of breast cancer bladder cancer non-small cell lung cancer and pancreatic cancer cells and plays a key role in the occurrence invasion and metastasis of these epithelial malignancies In conclusion Nectin-4 is one of the important targets for the diagnosis and treatment of many solid tumors The antibody-conjugated drug Enfortumab Vedotin targeting Nectin-4 was highly effective in Phase I clinical trials in 81 advanced bladder cancers and was awarded FDA breakthrough therapy in March 2018 Fibroblast activation protein FAP belongs to the serine protease family and is highly expressed on the surface of cancer-associat
Nectin-4 is a type I transmembrane protein whose extracellular domain is composed of three Ig-like domains V-C-C type which together with cadherin participate in the formation and maintenance of adhesion junctions Nectin-4 is ubiquitously expressed in human embryonic cells but is hardly expressed in normal adult tissues Nectin-4 is highly expressed on the surface of breast cancer bladder cancer non-small cell lung cancer and pancreatic cancer cells and plays a key role in the occurrence invasion and metastasis of these epithelial malignancies In conclusion Nectin-4 is one of the important targets for the diagnosis and treatment of many solid tumors The antibody-conjugated drug Enfortumab Vedotin targeting Nectin-4 was highly effective in Phase I clinical trials in 81 advanced bladder cancers and was awarded FDA breakthrough therapy in March 2018 Fibroblast activation protein FAP belongs to the serine protease family and is highly expressed on the surface of cancer-associat
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None