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.
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 treatment\'s 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 3+3 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
A novel universal CAR-T platform to treat cancer patients
Shenzhen Nanshan People's Hospital
Shenzhen, Guangdong, China
RECRUITINGFirst Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
RECRUITINGMaximum Tolerated Dose (MTD)
The highest dose of GCC-CAR-T cells that can be administered without causing unacceptable side effects, measured during the dose escalation phase.
Time frame: Within the first month post-infusion.
Dose-Limiting Toxicities (DLT)
The incidence of treatment-related toxicities that prevent further dose escalation.
Time frame: Within the first month post-infusion.
Treatment-Emergent Adverse Events (TEAE)
The frequency and severity of adverse events that arise following the administration of UWD-01-CAR-T cells.
Time frame: From the administration of UWD-01 CAR-T cells through six months post-infusion
Objective Response Rate (ORR)
The proportion of patients with a measurable reduction in tumor size (complete or partial response) following GCC-CAR-T therapy.
Time frame: Measured at 3 and 6 months after treatment.
Progression-Free Survival (PFS)
The length of time during and after treatment that the patient lives without disease progression.
Time frame: From the start of treatment up to 5 years.
Overall Survival (OS)
The duration from the start of treatment to the time of death from any cause.
Time frame: From the start of treatment up to maximum follow-up period of five years.
Duration of Response (DOR)
The time from initial tumor response (CR or PR) to disease progression or relapse or any cause of death.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From the administration of UWD-01 CAR-T cells to a maximum follow-up period of five years.