Clinical trial to administer patients’ own immune cells for terminal colon cancer with no treatment options

[Financial News] A clinical study using two types of immune cells extracted from patients’ own blood, cultured, and administered in sequence to combat terminal colon cancer is set to move forward in earnest.
The Ministry of Health and Welfare said on the 22nd that it had convened the 11th meeting in 2026 of the Review Committee on Advanced Regenerative Medicine and Advanced Biopharmaceuticals to review three clinical study plans submitted by regenerative medicine institutions. The committee ruled one appropriate and two inappropriate.
The plan deemed appropriate is a moderate-risk cell therapy clinical study in which patients with metastatic or recurrent terminal colon cancer will receive their own T lymphocytes and natural killer cells in sequence. T lymphocytes are a type of white blood cell that attacks cancer cells and virus-infected cells and activates other immune cells. Natural killer cells are part of the innate immune system and recognize and destroy abnormal cells, including tumor cells. Clinical studies in advanced regenerative medicine are classified as high, moderate, or low risk; studies using cultured cells derived from the patient are considered moderate-risk.
Metastatic or recurrent terminal colon cancer is stage IV, in which the cancer has spread to the liver, lungs, peritoneum, or other areas. When standard treatments such as surgery to remove the tumor or targeted anticancer therapy fail, there are no suitable treatment options.
The study will isolate natural killer cells and T lymphocytes from the blood of patients who have not responded to standard treatment, culture them for a set period, and then administer them in sequence. The researchers plan to assess the treatment’s safety and efficacy, including the proportion of patients whose cancer progression is suppressed or whose tumors shrink (the disease control rate), and the period during which the cancer does not worsen (progression-free survival).
The Ministry of Health and Welfare said it expects that, if the treatment’s efficacy is confirmed, it will provide patients with terminal colon cancer who have no other treatment options with a new option—personalized immune cell therapy—and help improve their quality of life.
“In this review, we examined plans to conduct advanced regenerative medicine studies targeting diseases that are difficult to treat, including terminal colon cancer,” said Kim Dong-ik, chair of the review committee. “We will carefully assess the validity of the plans based on scientific evidence so that new treatment possibilities can open up for patients with serious, rare, and intractable diseases.” He added, “I will do my utmost in the review process to ensure that advanced regenerative medicine can be safely applied to patients.”  


[email protected] Jung Myung-jin, Medical Correspondent Reporter