Ignite Creation Date:
2024-07-17 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478251
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-23
Brief Title:
NW-301 TCR-T in Patients With Advanced Solid Tumor
Sponsor:
TingBo Liang
Organization:
Zhejiang University
Study Overview
Official Title:
Open-label Single-arm Phase 1 Clinical Trial to Evaluate the Safety and Efficacy of Autologous TCR-T Cell Therapy in Subjects With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
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:
An open label two cohorts multiple dose exploratory clinical study to independently evaluate the safety efficacy and pharmacokinetics of autologous anti-KRAS G12VG12D mutation T-cell Receptor T cell in advanced solid tumor
Detailed Description:
This study is an open two cohorts single infusion dose escalationdose regimen finding study to independently assess the safety and pharmacokinetics of KRAS G12VG12D mutation TCR-T cell therapies and to obtain the preliminary efficacy results in subjects who have been diagnosed with advanced solid tumor with KRAS G12VG12D mutation and failed to standard systemic treatment
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