Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590246
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-01
Brief Title:
A Study to Evaluate C-CAR031 in Glypican-3 GPC3 Advancedrecurrent Hepatocellular Carcinoma HCC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase III Clinical Study of Armored and GPC3-targeted Autologous Chimeric Antigen Receptor CAR T-cell Infusion C-CAR031 in Participants with GPC3 Advancedrecurrent Hepatocellular Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
This single-arm open-label multicenter Phase III study will evaluate the safety tolerability anti-tumor activity pharmacokinetics PK pharmacodynamics PD and immunogenicity of C-CAR031 in adult participants with GPC3 advancedrecurrent HCC who have progressed or are intolerant to at least two prior lines of standardized systemic therapy and lack of other effective treatments
Detailed Description:
Part A Phase I is divided into two sections dose escalation Part A1 and dose expansion Part A2 Part A1 will determine the recommended dose for expansion RDE to be used in Part A2 dose expansion of the study Part A2 will further evaluate the safety tolerability and efficacy of C-CAR031 to determine the recommended phase II dose RP2D to be used in Part B Phase II
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