Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404281
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-04-21
Brief Title:
γδ T-PD-1 Ab Cells in the Treatment of Advanced Solid Tumors
Sponsor:
Changzhou No2 Peoples Hospital
Organization:
Changzhou No2 Peoples Hospital
Study Overview
Official Title:
Anti-PD-1 Antibody Armored γδ T Cells in the Treatment of Advanced Solid Tumors a Phase I Clinical Trail
Status:
RECRUITING
Status Verified Date:
2024-08
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 study intends to combine the advantages of γδ T cells and PD-1 monoclonal antibody to conduct an exploratory clinical study on the safety and efficacy of PD-1 antibody armored γδ T cells γδ T-PD-1 Ab cells in the treatment of advanced solid tumors
Detailed Description:
This is a single-center single-arm phase I clinical trial to evaluate the safety and efficacy of γδ T-PD-1 Ab cells in patients with advanced solid tumors without standard treatment A typical 33 dose-escalation design will be used to determine the optimal dose level of γδ T-PD-1 Ab cells based on the incidence of dose-limiting toxicity DLT The initial infusion dose level will start from 3107kg to 3108kg in every 2 weeks
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