An immune cell therapy for patients with advanced liver cancer and those with blood cancers at high risk of relapse has passed a government clinical review. Research to confirm a new treatment possibility for patients for whom standard therapy alone has had limits is expected to get underway in earnest.
The Ministry of Health and Welfare said on the 24th that it held the "8th Advanced Regenerative Medicine and Advanced Biopharmaceuticals Review Committee of 2026" on the 23rd and voted two of the six clinical study plans submitted by regenerative medicine institutions as suitable. The remaining four were deemed unsuitable.
The first project is an NK cell–based cell therapy study for patients with advanced hepatocellular carcinoma. Along with standard anticancer therapy and radiation therapy, a patient's own NK cells are cultured and activated, then reinfused.
Currently, the standard treatment for advanced hepatocellular carcinoma is a combination of an immune checkpoint inhibitor and a targeted anticancer drug, but the treatment effect often does not last long, and patients with comorbidities such as cirrhosis frequently find it difficult to continue therapy.
Through this trial, the researchers plan to assess safety while also evaluating objective response rate (tumor reduction), disease control rate, and progression-free survival (PFS).
The second project is an autologous CIK cell therapy study for patients with diffuse large B-cell lymphoma (DLBCL).
The subjects are patients who achieved complete remission with standard chemoimmunotherapy (R-CHOP) but are at high risk of relapse. The researchers plan to collect immune cells from the patients' blood, expand and activate them ex vivo, and administer them repeatedly to determine whether they can eliminate minimal residual disease and suppress relapse.
Diffuse large B-cell lymphoma is the most common non-Hodgkin lymphoma and is known to have a markedly worse prognosis upon relapse. In particular, in high-risk groups, there have not been many maintenance therapy options to prevent relapse, and the need for new treatments has been raised consistently.
The ministry said it expects this approval to expand the clinical application of advanced regenerative medicine technologies and broaden treatment options for patients with severe, rare, and intractable diseases.