SDT-T001 is a non genetically modified immune cell therapy drug developed by Cytocraft, which is suitable for both anti recurrence treatment after radical liver cancer surgery and for patients with advanced liver cancer who cannot undergo surgery and have poor radiation and chemotherapy effects. The core principle is to activate the patient's own immune cells, accurately attack tumor cells, and provide a full cycle solution for liver cancer patients from postoperative recurrence prevention to advanced treatment.

SDT-T001 is an immune cell therapy product developed based on central memory T cells (Tcm), which has essential differences compared to traditional liver cancer treatments such as chemotherapy and targeted drugs. Traditional treatments often directly kill tumor cells through external forces, and untargeted chemotherapy can also damage normal tissue cells, leading to serious side effects; SDT-T001 utilizes the homing ability of Tcm cells and can accurately migrate and nest to the site of liver cancer lesions after reinfusion, targeting and killing tumor cells with almost no damage to normal tissues and stronger specificity. Meanwhile, Tcm cells possess unique memory properties and can survive in the body for a long time, forming immune memory. They can continuously monitor and eliminate residual tumor cells in the body, achieving long-lasting anti-tumor effects.

SDT-T001 has currently advanced to Phase II clinical trial stage, focusing on further clinical research into recurrence risk management following curative treatment for liver cancer. Preliminary clinical study results suggest that SDT-T001 is generally manageable in terms of safety and tolerability, with observed trends of anti-tumor immune activity and potential reduction in postoperative recurrence risk. However, its efficacy and target patient population still require validation through subsequent confirmatory clinical trials with larger sample sizes and rigorous designs. Details regarding clinical data, potential benefits, and possible risks will be fully explained by physicians before patients decide to participate in the study or receive treatment. Patients are free to make their own informed decisions regarding participation.

The overall treatment cycle of SDT-T001 is about 8 months, divided into 3 core steps, all of which are completed in clinical partner hospitals: ① Cell collection: By collecting peripheral blood from the subject, the process is similar to blood donation, with a single dose lasting about 2-3 hours; ② Cell preparation: The collected cells are sent to a laboratory that meets GMP standards for screening, amplification, and cultivation of central memory T cells (Tcm). After strict quality inspection, they are reserved and take about 1-2 weeks; ③ Cell reinfusion: Tcm cells that have passed quality inspection are intravenously infused back into the patient's body for about 1-2 hours. After reinfusion, they need to be observed in the hospital for 1-2 days. If there are no abnormalities, they can be discharged. The specific process will be adjusted according to the patient's physical condition, and the doctor will provide detailed information in advance.

According to the observation results of the clinical use of SDT-T001 in the early stage, its side effects are mostly transient and lower than traditional chemotherapy, mainly manifested as low-grade fever (below 38.5 ℃), fatigue, chills, etc. after reinfusion, with an incidence rate of about 3.08%. It can usually be relieved on its own without special treatment. During the trial, the doctor will monitor your physical condition throughout the entire process and intervene promptly in case of any abnormalities to ensure your safety.

After enrollment, there is no need to bear any expenses related to the SDT-T001 clinical trial, including cell collection fees, preparation fees, infusion fees, follow-up fees during treatment, and hospitalization related to the trial. At the same time, every time you come to the hospital to participate in the trial (collection, reinfusion, re examination), you will receive a blood collection subsidy (if applicable) and a transportation subsidy. The specific amount will be informed by the doctor's assistant, and the subsidy will be paid on time after each visit.

SDT-M001 is a non genetically modified immune cell therapy product developed by Cytocraft, specifically designed for the prevention and treatment of postoperative recurrence of non-small cell lung cancer. Its core function is to activate self immune cells in a chain, enhance the body's anti-tumor immune ability, and reduce the risk of postoperative recurrence of non-small cell lung cancer. It is particularly suitable for non-small cell lung cancer patients who need further prevention and treatment after surgical resection.

Traditional treatments often involve staged killing of tumor cells, which can lead to recurrence after surgery due to residual tumor cells, and targeted drugs are prone to developing resistance; The CD8+tumor specific T killer cells in SDT-M001 are an important component that directly exert anti-tumor killing activity. After reinfusion, they can specifically identify non-small cell lung cancer tumor cells and achieve precise killing. At the same time, CD4+T helper cells can synergistically enhance the overall anti-tumor immune response of the body, eliminate residual tumor cells after surgery from the root, and reduce the risk of recurrence. The entire process adopts autologous cells and non genetic modification methods to activate the immune system and achieve anti-tumor effects without the toxic side effects of exogenous drugs.

The overall treatment cycle of SDT-M001 is about 2 months, divided into 3 core steps, all of which are completed in clinical partner hospitals: ① Cell collection: Collect the patient's own immune cells through a blood cell separator, similar to blood donation, with a single collection lasting about 3-4 hours. One collection is sufficient to meet the treatment needs; ② Cell preparation: The collected cells are sent to a laboratory that meets GMP standards, and a two-step cascade culture is used. Firstly, DC maturation is rapidly induced under the action of CD3 antibody activated T cell autocrine cytokines and exogenous cytokines. In the secondary activation, T cells undergo large-scale specific expansion under the induction of tumor specific antigens and cytokine activation, thereby obtaining a large number of tumors. After strict quality inspection, it is ready for use and takes about 5-6 weeks; ③ Cell reinfusion: Autoimmune cells that have passed quality inspection are intravenously infused back into the patient's body for about 0.5 hours. After reinfusion, they need to be observed in the hospital for 1-2 days. If there are no abnormalities, they can be discharged. The specific process will be adjusted according to the patient's physical condition, and the doctor will provide detailed information in advance.

SDT-M001 is currently undergoing Phase I clinical trials. Previous IIT studies have shown that the product can effectively activate the autoimmune function of postoperative non-small cell lung cancer patients, regulate the tumor microenvironment, and demonstrate good potential in reducing the risk of postoperative recurrence. The product has good safety and no serious adverse reactions have occurred.

Before enrollment, a baseline assessment examination must be completed, including blood routine, liver and kidney function, coagulation function, lung cancer tumor markers, electrocardiogram, chest imaging examination (CT), immune function testing, etc., to confirm whether your physical condition meets the enrollment requirements and establish baseline data for subsequent treatment efficacy monitoring. All examination fees related to enrollment will be fully borne by the sponsor, and you do not need to pay any fees. The examination results will be interpreted by the attending physician one by one.

The overall side effects of SDT-M001 are mild, transient, and self relieving. The common ones are low-grade fever (below 38.5 ℃), mild fatigue, and muscle soreness after reinfusion, which generally disappear on their own without the need for special treatment. A very small number of patients may experience mild nausea and rash. During the trial, a dedicated doctor will follow up on your physical condition throughout the entire process. If you experience any discomfort, you can contact the doctor at any time, and the doctor will provide you with timely treatment advice. According to the preliminary exploratory clinical observation results of SDT-M001, the safety of SDT-M001 treatment is good, and the common adverse reactions are mild (grade 1-2 NCI-CTCAE), mainly including fever, gastrointestinal reactions, and rash, which can generally be relieved on their own without special treatment. SDT-M001 treatment does not cause significant liver, kidney function, or hematological damage to the body.