Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06150885
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-29
First Post:
2023-11-13
Brief Title:
A Safety And Efficacy Study Of Allogeneic CAR Gamma-Delta T Cells in Subjects With RelapsedRefractory Solid Tumors
Sponsor:
Ever Supreme Bio Technology Co Ltd
Organization:
Ever Supreme Bio Technology Co Ltd
Study Overview
Official Title:
A Single Arm Open Label Dose-escalation Phase I and Dose-expansion Phase IIa Clinical Study to Evaluate the Feasibility Safety and Efficacy of Allogeneic Chimeric Antigen Receptor CAR Gamma-Delta T Cells CAR001 in Subjects With RelapsedRefractory Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
CAR001
Brief Summary:
This study is composed of phase I and IIa parts The dose-escalation phase I part aims to find the maximum tolerated dose MTD and to identify the safety of CAR001 in subjects with relapsedrefractory solid tumor the dose-expansion phase IIa part aims to evaluate the potential efficacy of CAR001 in subjects with relapsedrefractory non-small cell lung cancer NSCLC triple negative breast cancer TNBC colorectal cancer CRC or Glioblastoma multiforme GBM
Detailed Description:
Primary Objective
Phase I
To evaluate the safety of CAR001 in subjects
Phase IIa
To provide potential evidence for the clinical efficacy of CAR001 in improving tumor response rate in subjects
Secondary Objectives
To evaluate the safety and potential efficacy of CAR001 in subjects
Exploratory
Level of CAR-positive γδT cells in peripheral blood from baseline to subsequent visits Time Frame 12 months after the last infusion
Phase I
To evaluate the safety of CAR001 in subjects
Phase IIa
To provide potential evidence for the clinical efficacy of CAR001 in improving tumor response rate in subjects
Secondary Objectives
To evaluate the safety and potential efficacy of CAR001 in subjects
Exploratory
Level of CAR-positive γδT cells in peripheral blood from baseline to subsequent visits Time Frame 12 months after the last infusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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