Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619886
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
TP53 R248Q TCR-T Cell Therapy for Advanced Solid Tumor
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Early Clinical Study to Evaluate the Safety and Efficacy of TP53 R248Q Mutation-specific TCR-T Cell Therapy for Advanced Solid Tumor
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the safety and efficacy of T cell therapy with mutated TP53 R248Q specific TCR transduction in patients with advanced solid tumor expressing the TP53 R248Q mutation and the HLA-A1101 allele
Detailed Description:
Malignant tumors are a major disease threatening the health of the Chinese people with about 46 million new cancer patients and 2 million deaths each year in China P53 gene mutation is an important driver gene in the pathogenesis of malignant tumors P53 gene mutation is present in about half of cancer patients Tumors carrying P53 gene mutation are insensitive to treatment have poor response are easy to be resistant are easy to relapse and have a high mortality rate At present there is no drug that directly targets P53 gene mutation Our laboratory has previously built a TCR-T cell R D platform Using this platform we have successfully developed a TCR-T cell specific killing function for tumor cells targeting the R248Q mutation of the most common TP53 protein in hematological tumors and targeting the most high-frequency HLA-A1101 subtype of TCR-T cells in the Chinese population using in vitro and in vivo animal models and applied for a Chinese invention patent and PCT invention patent The findings provide new ideas and treatment methods for immune cell therapy of malignant tumors At present we cooperate with the hematology clinical team of Shanghai First Peoples Hospital and Shanghai Pharmaceutical Group Biotherapy Technology Co Ltd to prepare to carry out investigator-initiated clinical trials
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None