Clinical Study of Therapeutic Immunological Agent for EBV-positive Advanced Malignant Tumors

Launched by WEST CHINA HOSPITAL · Jan 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called a therapeutic immunological agent for patients with advanced malignant tumors that are positive for Epstein-Barr virus (EBV). The main goal of the trial is to determine how safe this treatment is and to see if it can effectively help patients whose previous treatments have not been successful. The trial is currently recruiting participants aged between 18 and 70 who have EBV-positive tumors and have not responded to at least two standard treatments, including a type of therapy called PD-1 inhibitors.

To be eligible, patients must be in relatively good health, with certain blood and organ function levels meeting specific requirements. Participants will be closely monitored for any side effects and how well the treatment works. It's important to note that individuals with severe heart issues, active infections, or other serious health problems may not qualify for the study. If you or someone you know is interested in this trial, it’s a good opportunity to contribute to important research while potentially accessing a new treatment option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female patients: ≥ 18 years old; ≤ 70 years old;
• • 2. Patients with EBV-positive advanced malignant tumors after failure of second-line standard therapy (including PD-1 inhibitor therapy);
• • 3. ECOG physical fitness score: 0\~1 points;
• • 4. Estimated survival ≥ 3 months;
• 5. The main organs have good function, that is, the relevant examination indicators within random 14 days meet the following requirements:
• • 1. Blood routine examination: hemoglobin ≥ 80 g/L (no blood transfusion within 14 days); Neutrophil count\> 1.5×109/L; Platelet count≥ 80×109/L;
• • 2. Biochemical examination: total bilirubin ≤ 1.5× ULN (upper limit of normal); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN; If liver metastases are present, ALT or AST ≤ 5×ULN; Endogenous creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula);
• • 3. Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF)
• • 50%.
• • 6. Sign the informed consent form;
• • 7. Good compliance, family members agree to cooperate with survival follow-up.
• Exclusion Criteria:
• • 1. Participated in clinical trials of other drugs within 4 weeks;
• • 2. The patient has a history of other tumors, unless it is cervical cancer in situ, treated cutaneous squamous cell carcinoma or bladder epithelial tumor or other malignant tumor that has received radical treatment (at least 5 years before enrollment)
• • 3. Patients with uncontrolled cardiac clinical symptoms or diseases, such asheart failure above NYHA grade 2, unstable angina, myocardial infarction within 1 year, and clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
• • 4. For female subjects: pregnant or lactating women.
• • 5. The patient has active tuberculosis, bacterial or fungal infection (≥ grade 2 of NCI-CTC, 3rd edition); There is HIV infection with active HBV infection, HCV infection.
• • 6. Those who have a history of psychotropic drug abuse and have mental disorders who cannot be remitted;
• • 7. The subject has any active autoimmune disease or has a history of autoimmune disease (such as, but not limited to uveitis, enteritis, pituitary inflammation, nephritis, hyperthyroidism, hypothyroidism,Participants with vitiligo or who had complete remission of asthma in childhood and did not require any intervention in adulthood could be included; Participants in asthma requiring medical intervention with bronchodilators were not included).
• • 8. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the patient's research.