Actively Recruiting
A Clinical Study to Evaluate the Safety and Efficacy of Anti-CEA CAR-T Cells in Treating Minimal Residual Disease After Surgery for Colorectal Cancer Liver Metastases
Led by Changhai Hospital · Updated on 2022-03-11
18
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effectiveness of anti-CEA CAR-T cell therapy in patients with colorectal cancer who have liver metastases and have undergone complete tumor removal surgery (R0 resection). This phase I clinical trial focuses on patients with minimal residual disease detected by positive circulating tumor DNA (ctDNA), which may lead to recurrence. The study builds on promising preclinical results showing good safety and potential effects of anti-CEA CAR-T cells targeting tumors expressing carcinoembryonic antigen (CEA). Participants will receive intravenous infusions of anti-CEA CAR-T cells at varying doses (1x10^6/kg, 3x10^6/kg, and 6x10^6/kg) using a standard dose-escalation design to determine the maximum tolerated dose. The study includes patients with positive minimal residual disease after surgery and adjuvant chemotherapy, without visible tumors on imaging. The trial will evaluate safety, treatment impact on minimal residual disease, and recurrence-free survival over a two-year period post-infusion. During the study, participants will be closely monitored for adverse events within 28 days after CAR-T cell infusion. Researchers will assess minimal residual disease status and recurrence-free survival for up to two years following treatment. Pharmacokinetics of the infused cells will also be studied over this period. Participants will undergo regular evaluations including imaging and laboratory tests to track treatment effects and safety throughout the trial.
CONDITIONS
Brief Title
Anti-CEA CAR-T Cells to Treat Colorectal Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, male or female
- Diagnosed with colorectal cancer liver metastasis with complete (R0) surgical removal of primary and liver tumors
- No measurable tumors or visible remnants on imaging after surgery
- CEA expression in primary and liver metastasis tumors detected by pathology is over 50%
- Life expectancy of at least 6 months
- Performance status score 0-2 and Karnofsky score above 60
- Positive circulating tumor DNA minimal residual disease after adjuvant chemotherapy
- Adequate organ function including heart, liver, kidney, and lung
- Sufficient mononuclear cells can be collected from peripheral blood
- Patients of childbearing age must use effective contraception and have no plans to conceive within 1 year after infusion
You will not qualify if you...
- History of severe central nervous system diseases
- Visible tumor remnants on imaging or unresectable tumors in other organs
- Serious non-cancer diseases including autoimmune, primary immunodeficiency, or severe respiratory diseases
- Prior treatment with CAR-T or other gene-modified T cells
- Participation in other clinical trials within 30 days before screening or during this study
- Active infections such as high viral load Hepatitis B or C, HIV, or syphilis at screening
- Uncontrolled systemic infections
- Multiple cancers other than colorectal cancer and its metastases
- Use of immunosuppressants or glucocorticoids within 2 weeks before or during the trial
- Pregnancy or breastfeeding
- Severe gastrointestinal inflammation or ulcers
- Inability to provide enough tumor tissue samples for genetic testing
- Other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days after CAR-T cells infusion
Participants receive intravenous infusions of anti-CEA CAR-T cells at varying doses to evaluate safety and efficacy.
1 infusion visit plus frequent monitoring visits during 28 days
Duration - Up to 2 years after CAR-T cells infusion
Participants are monitored for long-term outcomes including minimal residual disease status and recurrence-free survival.
Periodic visits over 2 years for assessments
Trial Site Locations
Total: 1 location
1
Department of Colorectal Surgery in Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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