Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653010
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Universal CAR-T Cells REVO-UWD-01 for Metastatic Colorectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Clinical Study on the Safety and Efficacy of Universal CAR-T Cells REVO-UWD-01 for Metastatic Colorectal Cancer
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:
Wondercel-UWD1
Brief Summary:
This is an investigator initiated trial to assess the efficacy and safety of a GCC-targeting CAR-T therapy REVO-UWD-01 in the metastatic colorectal cancer It also aims to explore the feasibility of using a novel universal CAR-T cell platform
Detailed Description:
The study will use T cells from healthy donors modified using a novel universal CAR-T technology to treat metastatic colorectal cancer patients The antigen-binding site of the CAR molecule recognizes GCC as the target
The main questions it aims to answer are
What is the maximum tolerated dose MTD of GCC-CAR-T therapy in universal CAR-T cell treatments
What are the dose-limiting toxicities DLT and treatment-emergent adverse events TEAE
What is the treatmentampamp39s efficacy as measured by objective response rate ORR and progression-free survival PFS Researchers will assess whether universal CAR-T cells have good safety and efficacy in treating colorectal cancer while improving accessibility and lowering treatment costs
Participants will
Receive universal GCC-CAR-T cells through a 33 dose escalation scheme
Undergo chemotherapy conditioning before CAR-T infusion
Be monitored for adverse events immune response and disease progression
The study will collect data on both short-term outcomes within the first few months post-treatment and long-term safety and efficacy
The main questions it aims to answer are
What is the maximum tolerated dose MTD of GCC-CAR-T therapy in universal CAR-T cell treatments
What are the dose-limiting toxicities DLT and treatment-emergent adverse events TEAE
What is the treatmentampamp39s efficacy as measured by objective response rate ORR and progression-free survival PFS Researchers will assess whether universal CAR-T cells have good safety and efficacy in treating colorectal cancer while improving accessibility and lowering treatment costs
Participants will
Receive universal GCC-CAR-T cells through a 33 dose escalation scheme
Undergo chemotherapy conditioning before CAR-T infusion
Be monitored for adverse events immune response and disease progression
The study will collect data on both short-term outcomes within the first few months post-treatment and long-term safety and efficacy
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