Using Anti-CEA CAR-T Cells to Treat Liver Metastases from Colorectal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of Anti-CEA CAR-T cells to target and treat liver metastases in patients with colorectal cancer. The approach focuses on patients who have undergone radical surgery for their primary colorectal cancer and have no measurable disease, yet still show signs of minimal residual disease through circulating tumor DNA. The study aims to evaluate the safety and effectiveness of this innovative immunotherapy in a Phase 1 setting, potentially addressing a significant gap in treatment for solid tumors. By targeting carcinoembryonic antigen (CEA), which is often elevated in gastrointestinal tumors, the trial seeks to improve outcomes for patients at risk of recurrence.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. ≥18 years old, ≤75 years old, male or female;
2. Patients diagnosed with liver metastasis of colorectal cancer underwent radical surgery for the primary lesion of colorectal cancer, and R0 resection was performed for the liver metastasis (R0 resection was required for other organ metastasis). There was no measurable disease or tumor remnants (except invisible or unmeasurable disease) were found by imaging examination after surgery;
3. Patients with CEA expression detected by immunohistochemistry in primary tumor and liver metastasis tumor tissues (CEA expression detected by pathology was more than 50%);
4. Life expectancy ≥6 months;
5. Performance status (PS) score 0-2, Karnofsky performance status (KPS) score above 60;
6. Patients with ctDNA MRD still positive or positive again after adjuvant chemotherapy (including preoperative neoadjuvant chemotherapy);
7. Important organ functions are sufficient, such as New York Heart Association (NYHA) heart function grade III or above, hemoglobin ≥90g/L, hypoxia; Liver function: total bilirubin ≤1.5×ULN (total bilirubin ≤3×ULN in liver metastasis), ALT≤2.5×ULN, AST≤2.5×ULN (ALT or/and AST≤5×ULN in liver metastasis); Renal function: serum creatinine ≤1.5×ULN and creatinine clearance rate ≥50 mL/min. The creatinine clearance rate was only calculated when serum creatinine ≤1.5×ULN. Minimum reserve of lung function (dyspnea no higher than grade 1 and oxygen saturation \> 91% without oxygen);
8. Sufficient mononuclear cells (PBMC) can be obtained from peripheral veins without contraindications;
9. Patients of childbearing age had no birth plan within 1 year after cell infusion and took effective contraceptive measures.

Exclusion Criteria:

1. Have a history of severe central nervous system diseases;
2. Residual disease or tumor remnants can be seen in imaging, or tumor lesions cannot be resected in other tissues or organs;
3. The presence of serious non-malignant diseases, including autoimmune diseases, primary immunodeficiency diseases or obstructive or restrictive respiratory diseases;
4. Prior treatment with CAR-T or other gene-modified T cells;
5. Participated in other clinical studies within 30 days prior to screening or plan to participate in other clinical studies during the study period;
6. Patients with active Hepatitis B (HBV-DNA copy number \>105copies/ml), active Hepatitis C (HCV-RNA copy number \>ULN), HIV infection, treponema pallidum infection at screening time;
7. The existence of uncontrollable systemic infectious diseases;
8. Other multiple malignant tumors in addition to colorectal cancer and its metastasis;
9. Chinese herbal medicine, systemic glucocorticoids or other immunosuppressants may be required within 2 weeks prior to enrollment or during the trial period, which may negatively affect lymphocyte activity or number;
10. Pregnancy and lactation;
11. The existence of severe gastroduodenal ulcer, severe ulcerative colitis and other serious intestinal inflammation;
12. The existence of serious respiratory diseases;
13. Those who cannot provide enough white tablets for tumor pathology for next-generation sequencing (NGS) detection (at least 3 white tablets are expected);
14. The investigator judged that there were other conditions that were not suitable for the clinical study.

Where it's running

• Department of Colorectal Surgery in Changhai Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

  This trial tries CD5 CAR T-cell therapy, using either the patient's own cells or donor cells, and may bridge to stem-cell transplant for people 14–70 with relapsed or refractory T-cell lymphoma.

  Recruiting at 3 sites Phase 1/2 Beijing GoBroad Hospital · Beijing and 2 other locations · NCT07022964

• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

  This trial tests whether the antibody drug glofitamab given with obinutuzumab can shrink or control mantle cell lymphoma that returned or didn't respond after CD19 CAR‑T therapy in adults.

  Recruiting at 11 sites Phase 2 National Cancer Institute (NCI) · Duarte, California and 10 other locations · NCT07003295

• CD7 CAR T-Cell Therapy for T-Cell Lymphomas

  This study is testing a new CAR T-cell therapy for people with T-cell lymphomas that haven't responded to regular treatments to see if it is safe and effective.

  Recruiting at 4 sites Phase 1/2 Beijing GoBroad Hospital · Beijing, Beijing Municipality and 3 other locations · NCT06925464

• Using golcadomide and rituximab to prepare patients for CAR T-cell therapy in aggressive B-cell lymphoma

  This study is testing if a combination of golcadomide and rituximab can help patients with aggressive B-cell lymphoma get ready for CAR T-cell therapy.

  Recruiting at 7 sites Phase 2 Mayo Clinic · Scottsdale, Arizona and 6 other locations · NCT06834373

• Treatment of advanced cancers using CEA-targeted CAR-T cells

  This study is testing a new type of CAR-T cell treatment for people with advanced cancers that have a specific marker, to see if it is safe and how well it works for those who haven't had success with other treatments.

  Recruiting Phase 1 Zhejiang University · Hangzhou, Zhejiang · NCT06821048

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.