Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06215950
Status:
RECRUITING
Last Update Posted:
2024-01-22
First Post:
2024-01-11
Brief Title:
A Clinical Research About CD70-targeted CAR-T in the Treatment of CD70-positive AdvancedMetastatic Gynecologic Cancer
Sponsor:
Chongqing Precision Biotech Co Ltd
Organization:
Chongqing Precision Biotech Co Ltd
Study Overview
Official Title:
A Phase I Clinical Study to Assess the Safety and Efficacy of CD70-targeted CAR-T in the Treatment of CD70-positive AdvancedMetastatic Gynecologic Cancer
Status:
RECRUITING
Status Verified Date:
2024-01
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:
This is a single-center double-arm open-label study this study plans to evaluate the safety and efficacy of CD70-targeting CAR-T cells in the treatment of CD70-positive advancedmetastatic Gynecologic Cancer and obtain recommended doses and infusion patterns
Detailed Description:
The research designs to follow 2 groupsIntravenous infusion group and Intraperitoneal injection groupeach group sets up 2 phasesthe first phase is dose discovery phase to obtain recommended dosesthe second phase is dose expansion phase to verify the safety in the recommended doses In the discovery phaseeach group puts up 4 dose groups adopting a dose-escalating 33 design and plan to recruit about 12 subjects with CD70-positive advancedmetastatic solid tumorsIn the dose expansion phaseeach group will choose one or two dose groups to verify the safety and efficacy at this doseand plan to recruit about 6 subjects in each dose group
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