Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652243
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Clinical Study of SN301A Injection in the Treatment of Hepatocellular Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Early Clinical Study to Evaluate the Safety and Efficacy of SN301A Cell Injection in the Treatment of Subjects with Glypican-3 GPC3-Positive Advanced Hepatocellular Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
SN301A
Brief Summary:
This is a single-arm open-label study of safety tolerability and anti-cancer activity of SN301A an off-the-shelf CAR NK cell therapy in patients with glypican-3 GPC3-positive advanced hepatocellular carcinoma
Detailed Description:
This study is a single-arm open-label modified 33 dose-escalation early exploratory clinical study to evaluate the safety tolerability Pharmacokinetic PK and Pharmacodynamic PD of SN301A cell injection in the treatment of subjects with glypican-3 GPC3-positive advanced hepatocellular carcinoma and evaluate the efficacy of SN301A cell injection in the treatment of subjects with GPC3-positive advanced hepatocellular carcinoma
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