Huwei Township

Researchers are evaluating the safety, tolerability, and anticancer activity of CHO-H01 in people with relapsed or refractory CD20-positive non-Hodgkin's lymphoma. This study has two parts: Phase 1 aims to find the maximum tolerated dose and recommended Phase II dose of CHO-H01. Phase 2a will assess the combination of CHO-H01 with lenalidomide in subjects with low-grade relapsed/refractory CD20-positive non-Hodgkin's lymphoma, including follicular lymphoma, marginal zone lymphoma, and small lymphocytic lymphoma. In Phase 1, CHO-H01 is given as an intravenous infusion once a week for 4 weeks in the first 28-day cycle, then once on Day 1 of each subsequent 21-day cycle, continuing until disease progression or up to 6 cycles (about 19 weeks). After determining the recommended dose, Phase 2a starts where CHO-H01 is given at that dose weekly for 4 weeks, then once on Day 1 of each 28-day cycle combined with oral lenalidomide 20 mg daily from Day 1 to Day 21 of each cycle. Treatment continues until disease progression or for up to 6 cycles. Participants will be monitored throughout the study, which lasts approximately 16 months, for safety and treatment responses. Researchers will track adverse events, dose-limiting toxicities, objective response rates, and best overall response. Assessments include physical exams, tumor measurements, heart function checks, and tumor biopsies if needed, ensuring careful evaluation of treatment effects and participant safety.

Researchers are evaluating whether adding high-dose-rate (HDR) brachytherapy can improve treatment outcomes for patients with locally advanced esophageal squamous cell carcinoma (ESCC). This study focuses on patients who have already received external beam radiotherapy (EBRT), chemotherapy with platinum and fluoropyrimidine, and the immune therapy drug nivolumab. The goal is to see if HDR brachytherapy can reduce the chance of cancer returning in the esophagus or nearby areas within 12 months, while also monitoring for side effects and safety. Participants will receive 1-2 sessions of HDR brachytherapy delivered through a thin tube placed inside the esophagus within three weeks after starting nivolumab. The HDR brachytherapy dose ranges from 5 to 12 Gy in 1-2 fractions. Nivolumab is given intravenously at a dose of 240 mg every two weeks for at least two doses, continuing through and after brachytherapy as long as the disease does not progress or unacceptable side effects occur. Brachytherapy planning involves CT scans to position the applicator and target the tumor precisely, aiming to spare healthy tissue. During the study, participants will have regular follow-up visits, imaging tests, and blood samples to monitor treatment response and safety. Researchers will measure the cumulative incidence of locoregional failure at 12 months, along with secondary outcomes like overall survival, progression-free survival, tumor response rates, and safety. The total participation period includes the screening phase, treatment cycles, and follow-up monitoring to assess the impact of combining HDR brachytherapy with immunotherapy and radiotherapy.

Research Background and Current Status of Medical Technology According to data from the Ministry of Health, cancer has consistently ranked as the leading cause of death in Taiwan. Although various treatments for cancer, including surgery, chemotherapy, and radiotherapy, are currently available, there is still significant room for improvement in terms of extending survival and reducing side effects. Recently, research on natural killer (NK) cell therapy has gained attention both domestically and internationally. While the therapeutic effects remain uncertain and most countries are still in the clinical trial stage, preliminary results and studies from other countries suggest that combining NK cell therapy with traditional treatments like chemotherapy or radiotherapy may provide additional benefits for cancer patients. Natural killer cells are among the first-line innate immune defenses in the human body and are considered one of the most potent and effective cells for combating cancer and viral infections. Compared to other anti-cancer immune cells, such as cytotoxic T cells or dendritic cells, NK cells exhibit stronger cytotoxicity, a broader spectrum of activity, and are not restricted by tissue compatibility antigens. They can directly attack cancer cells without the need for prior sensitization. Since the discovery of NK cells in the 1970s, immunologists have hypothesized that expanding NK cells in large quantities and reinfusing them into patients could achieve anti-cancer effects, enhance immune regulation, and improve overall immunity. This forms the theoretical basis of NK cell therapy. In simple terms, NK cell therapy involves the use of cell culture techniques to rapidly proliferate a patient's NK cells in vitro and then reinject them into the patient. This approach aims to boost the patient's innate anti-cancer capacity and support conventional therapies in achieving cancer treatment goals. Laboratory studies using animal models and in vitro experiments have highlighted several theoretical advantages of NK cell therapy for cancer treatment: 1. NK cells exhibit the strongest anti-cancer activity in the human body, directly killing cancer cells and inhibiting tumor growth and spread. 2. NK cells suppress the formation of new blood vessels around tumors, restricting the supply of nutrients necessary for tumor growth. Although the clinical effectiveness of NK cell therapy for cancer in humans has yet to be confirmed, some preliminary international studies suggest that adding activated NK cells or cytokine-induced killer (CIK) cells to standard treatments may help inhibit the spread of cancer cells and slow disease progression. Characteristics of Human Cell Therapy Products and Usage Experience 1. Cell Source and Characteristics Source: Autologous cells Characteristics: Dendritic cells (DCs) have the ability to activate adaptive immune functions. NK cells possess tumor-killing capabilities. Rationale for Use in This Indication: Preliminary clinical studies indicate that in non-small cell lung cancer (NSCLC) patients, groups receiving NK cell (or NK + DC) immunotherapy in addition to traditional treatments (surgery, chemotherapy, or radiotherapy) showed better outcomes in individual trials compared to control groups that received only traditional treatments. These outcomes included improved objective response rates (ORR), progression-free survival (PFS), overall survival (OS), and, in some cases, enhanced quality of life (refer to the summary table on the next page for details). 2. Usage Experience Numerous clinical trials have already been conducted internationally. The investigational drug in this trial is being tested in humans for the first time.