Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419166
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-04-25
Brief Title:
An Exploratory Clinical Study of GC012F Injection for Refractory gMG
Sponsor:
Zhejiang University
Organization:
Zhejiang University
Study Overview
Official Title:
An Exploratory Clinical Study of GC012F Injection for the Treatment of Refractory Generalized Myasthenia Gravis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
gMG
Brief Summary:
This study is a single-arm open-label early exploratory clinical trial designed to evaluate the safety tolerability and preliminary efficacy of GC012F injection in subjects with refractory GMG Additionally the study aims to assess the pharmacokinetic PK pharmacodynamic PD characteristics and immunogenicity of GC012F injection in subjects
Detailed Description:
This study is a single-arm open-label early exploratory clinical trial designed to evaluate the safety tolerability and preliminary efficacy of GC012F injection in subjects with refractory GMG Additionally the study aims to assess the pharmacokinetic PK pharmacodynamic PD characteristics and immunogenicity of GC012F injection in subjects
The trial consists of several phases screening period apheresis day baseline period lymphodepletion period pre-infusion assessment period GC012F infusion period safety and efficacy follow-up period long-term follow-up period and study discontinuation visit if applicable
Qualified subjects will undergo apheresis and receive the infusion after the production of CAR-T products Subjects will undergo lymphodepletion before CAR-T cell infusion and assessment before infusion Subjects meeting the cell infusion criteria will receive CAR-T cell infusion according to the dose specified in the protocol Dose adjustments may occur based on safety and clinical efficacy for subjects in the same group or subsequent trial groups
The trial consists of several phases screening period apheresis day baseline period lymphodepletion period pre-infusion assessment period GC012F infusion period safety and efficacy follow-up period long-term follow-up period and study discontinuation visit if applicable
Qualified subjects will undergo apheresis and receive the infusion after the production of CAR-T products Subjects will undergo lymphodepletion before CAR-T cell infusion and assessment before infusion Subjects meeting the cell infusion criteria will receive CAR-T cell infusion according to the dose specified in the protocol Dose adjustments may occur based on safety and clinical efficacy for subjects in the same group or subsequent trial groups
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