A groundbreaking clinical study is set to begin, focusing on cell therapy for high-risk diffuse large B-cell lymphoma (DLBCL) patients. This aggressive form of cancer poses a significant risk of relapse, even when patients achieve complete remission with no detectable cancer cells.

On Wednesday, Seoul St. Mary's Hospital announced that a research team led by Professor Min Gi-jun from the Department of Hematology has secured final approval for their project under the Ministry of Health and Welfare's 2026 Second Advanced Regenerative Medicine Clinical Research Activation Support Project.

With this green light, Professor Min's team will launch a clinical study aimed at preventing relapse in high-risk DLBCL patients.

Seoul St. Mary's Hospital will spearhead this multi-center, prospective, randomized controlled study, which is slated to run for 21 months with a substantial research budget of approximately 29 billion KRW (about 21 million USD).

The study will bring together a team of esteemed hematology experts, including Professors Min, Eom Gi-seong, and Choi Yoon-seok.

DLBCL, the most prevalent form of non-Hodgkin lymphoma, is a particularly challenging blood cancer to treat.

Despite achieving complete remission through immunotherapy, about 30% of high-risk patients face the daunting prospect of relapse within two years.

The absence of a standardized maintenance therapy to prevent relapse leaves many patients, even those in complete remission, grappling with the constant fear of recurrence.

To address this critical gap in treatment, the research team is set to validate an innovative approach: autologous cytokine-induced killer (CIK) cell therapy, which harnesses the power of the patient's own immune cells.

CIK cells are remarkable in their ability to recognize stress proteins on cancer cell surfaces through specialized receptors. Once identified, these cells release potent substances that target and destroy the cancerous cells.

The team hypothesizes that CIK therapy could significantly reduce the presence of microscopic residual cancer cells that may linger after chemotherapy, thereby lowering the risk of relapse.

The treatment protocol involves a sophisticated process: immune cells are harvested from the patient's peripheral blood, then activated and multiplied in an advanced regenerative medicine cell manufacturing facility (GMP), before being reintroduced to the patient through repeated administrations.

A key advantage of this autologous cell therapy is its use of the patient's own immune cells, which substantially mitigates the risk of immune rejection often associated with therapies using cells from other individuals.

Unlike traditional cytotoxic chemotherapy regimens, CIK cell therapy aims to bolster anti-tumor immune responses without significantly compromising the patient's overall immune function.

This approach is expected to enhance the body's natural surveillance against any lingering cancer cells post-remission, potentially reducing the likelihood of relapse.

The research team's confidence in this approach is bolstered by their previous findings from a prospective clinical study. In that study, they demonstrated both the safety and potential relapse-suppressing effects of CIK therapy in high-risk lymphoma patients who had undergone autologous stem cell transplantation.

Building on these promising results, the current study aims to extend this treatment strategy to high-risk DLBCL patients, comparing its efficacy and safety against a standard observation group.

The study's robust design includes a total of 120 patients, evenly split between the treatment and control groups, with 60 participants in each.

To ensure the utmost scientific rigor, participants will be randomly assigned to either group using a sophisticated computer program. This randomization process will take into account critical factors such as individual risk profiles and participating hospitals, ensuring a balanced distribution between the two groups.

To maintain the highest standards of data integrity and patient safety, the research data will be managed and independently analyzed by a separate clinical trial organization. Additionally, a dedicated monitoring committee will oversee safety protocols throughout the study.

The research team will use the two-year disease-free survival rate as their primary endpoint, providing a comprehensive assessment of both the relapse suppression efficacy and overall safety profile of CIK cell therapy.

Set to launch in October, this groundbreaking study will focus on high-risk DLBCL patients who achieve complete remission following standard first-line treatment.

Professor Min highlighted the unique advantages of their approach, stating that while most cancer treatments can compromise a patient's immune function, autologous CIK cell therapy works by activating the patient's own immune cells, enhancing anti-tumor immune responses.

He added that the goal is to rigorously validate whether autologous CIK cell therapy can effectively reduce relapse risk in high-risk DLBCL patients. It's committed to developing this into a novel treatment strategy that offers tangible benefits to patients.

It's worth noting that Seoul St. Mary's Hospital has been at the forefront of regenerative medicine since its designation as the first advanced regenerative medicine institution among domestic university hospitals in 2021. The hospital has been pioneering research in next-generation therapies utilizing stem cells and immune cells.

The hospital's research team has already achieved several groundbreaking successes, including the world's first successful treatment of immunocompromised patients suffering from chronic COVID-19 using customized T-cell therapies.

A groundbreaking clinical study is set to begin, focusing on cell therapy for high-risk di …

2026 Breakthrough: How CIK Cell Therapy Aims to Prevent Relapse in High-Risk DLBCL Patients