Immune Modulation With PRaG-1 Treatment

Launched by SECOND AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · May 25, 2025

Keywords

ClinConnect Summary

This clinical trial, called "Immune Modulation With PRaG-1 Treatment," is exploring a new treatment for patients with advanced solid tumors, which are types of cancer that form in organs or tissues. The study is in the second phase and will take place at one medical center. To participate, patients must have a history of certain cancers (excluding some skin cancers) and be willing to take a medication called PRaG-1 twice a day for 10 days. Before starting the treatment, and again during and after, doctors will conduct blood tests to monitor the immune response.

Eligible participants include adults who do not have uncontrolled health issues, such as serious heart problems or active infections, and are not currently receiving medications that suppress the immune system. Patients with certain past medical conditions, such as severe mental health issues or significant immune system disorders, may also be excluded from the trial. This trial is not yet recruiting participants, but if you meet the eligibility criteria and are interested in learning more, it could be an opportunity to explore a potential new treatment option for cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with a history of other malignant diseases within the past 5 years, except for curatively treated skin cancer and cervical carcinoma in situ; Patients with a history of uncontrolled epilepsy, central nervous system diseases, or psychiatric disorders, which, in the judgment of the investigator, may impair the ability to sign the informed consent form or affect the patient's compliance with drug treatment; Clinically significant (i.e., active) cardiovascular disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or worse congestive heart failure, or severe arrhythmias requiring medication, or a history of myocardial infarction within the past 12 months; Patients currently receiving immunosuppressive therapy; Known active major infections, or significant hematological, renal, metabolic, gastrointestinal, endocrine dysfunction, or other serious uncontrolled comorbid conditions, as determined by the investigator; Patients with hypersensitivity to any component of the investigational drugs; History of immunodeficiency, including positive HIV test results or other acquired or congenital immunodeficiency diseases, history of organ transplantation, or other immunologically related conditions requiring long-term oral steroid therapy; Other conditions deemed unsuitable for enrollment by the investigator.
• Exclusion Criteria:
• • Patients with a history of any other malignant diseases within the past 5 years are excluded, except for curatively treated skin cancer and cervical carcinoma in situ.
• • Patients with a history of uncontrolled epilepsy, central nervous system diseases, or psychiatric disorders are excluded if, in the judgment of the investigator, these conditions may impair the ability to sign the informed consent form or affect the patient's compliance with drug treatment.
• • Clinically significant (active) cardiovascular disease is excluded, including symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or worse congestive heart failure, severe arrhythmias requiring medication, or a history of myocardial infarction within the past 12 months.
• • Patients currently receiving immunosuppressive therapy are excluded. Known active major infections are excluded, as are significant hematological, renal, metabolic, gastrointestinal, endocrine dysfunction, or other serious uncontrolled comorbid conditions, as determined by the investigator.
• • Patients with hypersensitivity to any component of the investigational drugs are excluded.
• • History of immunodeficiency is excluded, including positive HIV test results, other acquired or congenital immunodeficiency diseases, history of organ transplantation, or other immunologically related conditions requiring long-term oral steroid therapy.
• • Other conditions deemed unsuitable for enrollment by the investigator are excluded.