Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616727
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
The Safety and Efficacy of SNC-109 CAR-T Cells Therapy the rGBM
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Study to Evaluate the Safety Tolerability and Pharmacokinetics of SNC109 in Patients With Recurrent Glioblastoma
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
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:
A phase I study to evaluate the safety tolerance and pharmacokinetics of SNC109 in patients with rGBM
Detailed Description:
It is planned to recruit about 50 patients with rGBM subjects The protocol consists of screening period Lymphocytes apheresis period Operation period pre-infusion evaluation -2-1 days infusion day 0 infusion observation day 1-post infusion and follow-up period last infusion-720 days The incidence of dose limitation toxicity DLT will be observed within 28 days after the first infusion Subjects in this study will receive multiple infusions starting with 5104 CAR T cellsdose in the first subject and the Safety Review Committee SRC will evaluate the subsequent dosing regimen dose infusion interval and number of treatment cycles Subsequent subjects will be evaluated by the SRC on the basis of available PK and safety data and the SRC will determine the dosing regimen dose infusion interval and number of treatment cycles based on observed evidences
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