The autologous immune cell induction technology used in this project involves transforming peripheral blood mononuclear cells (PBMC) into autologous DC cells, NK cells, CIK cells and other immune cells through cytokine induction, and then re-administering them to the patients. This therapy utilizes biotechnology to culture the immune cells of cancer patients in vitro and then re-infuse them back into the body, stimulating and enhancing the body's own immune function, killing and inhibiting cancer cells, eliminating small and residual lesions, or achieving the goal of treating cancer by significantly inhibiting the proliferation of residual cancer cells.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The participant must voluntarily participate in the study and provide written informed consent。
✓. Age ≥ 18 years, male or female.
✓. Histologically and/or cytologically confirmed locally advanced or metastatic solid tumor: lung cancer, liver cancer, colorectal cancer, or breast cancer.
✓. Has not received any other cellular immunotherapy within 3 months prior to enrollment.
✓. Has at least one measurable lesion according to RECIST (Response Evaluation Criteria in Solid Tumors) Version 1.1.
✓. Adequate organ function, defined as follows:
Exclusion criteria
✕. Prior receipt of any salvage chemotherapy, implanted intraperitoneal chemotherapy, targeted therapy, or biological immunotherapy (except: patients whose disease progressed more than 6 months after completing adjuvant, neoadjuvant, or radiosensitizing chemotherapy, or more than 1 month after intraperitoneal chemoperfusion/wash, are eligible, provided chemotherapy-related toxicities have recovered to Grade 1 or below, excluding alopecia).
What they're measuring
1
Phase II Primary Outcome: Objective Response Rate (ORR)
Timeframe: From randomization until disease progression, assessed up to approximately 24 months
2
Phase I Primary Outcome: Incidence of Adverse Events (AEs)
Timeframe: From cell infusion up to 3 months after the last infusion
Trial details
NCT IDNCT07260058
SponsorLiaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd.
✕. Major surgical procedure within 4 weeks prior to enrollment, with incomplete recovery from side effects.
✕. History of any active malignancy within 5 years, except for the specific cancer under investigation in this trial and cured localized tumors such as carcinoma in situ of the cervix, basal cell carcinoma of the skin, and prostate carcinoma in situ.
✕. Presence of more than a small amount of pericardial effusion, or uncontrolled pleural or peritoneal effusion, defined as: detectable by physical examination at screening, or requiring therapeutic paracentesis during the screening period.
✕. Inability to tolerate peripheral blood collection due to various reasons (e.g., severe coronary heart disease, inability to establish peripheral venous access).
✕. Severe cardiovascular disease, including uncontrolled hypertension, unstable angina, history of myocardial infarction within the past 6 months, congestive heart failure \> NYHA (New York Heart Association) Class III, or severe arrhythmia.
✕. Active infection, unexplained fever ≥ 38.5°C within 7 days prior to medication, or baseline white blood cell count \> 15×10⁹/L; OR any severe acute or chronic infection requiring systemic antibacterial, antifungal, or antiviral therapy at screening (except for active hepatitis).
✕. Any active autoimmune disease or history of autoimmune diseases (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Patients with vitiligo; Patients with childhood asthma that has completely resolved in adulthood without any intervention are eligible; Asthma requiring bronchodilator medical intervention is excluded). Patients are eligible if: they have a history of autoimmune-related hypothyroidism and are on stable thyroid hormone replacement therapy; or have type I diabetes controlled by insulin therapy.