Clinical Study of Therapeutic Immunological Agent for EBV-positive Advanced Malignant Tumors (NCT05707910) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Clinical Study of Therapeutic Immunological Agent for EBV-positive Advanced Malignant Tumors
China6 participantsStarted 2023-02-08
Plain-language summary
To evaluate the safety of therapeutic immunological agent against EBV-positive advanced malignancies, examining the incidence, type of occurrence, and severity of adverse events in relation to the agent tested, and initially exploring the effectiveness of the immunological agent.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male or female patients: ≥ 18 years old; ≤ 70 years old;
✓. Patients with EBV-positive advanced malignant tumors after failure of second-line standard therapy (including PD-1 inhibitor therapy);
✓. ECOG physical fitness score: 0\~2 points;
✓. Estimated survival ≥ 3 months;
✓. The main organs have good function, that is, the relevant examination indicators within random 14 days meet the following requirements:
✓. Blood routine examination: hemoglobin ≥ 80 g/L (no blood transfusion within 14 days); Neutrophil count\> 1.5×10\^9/L; Platelet count≥ 80×10\^9/L;
✓. 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);
✕. Participated in clinical trials of other drugs within 4 weeks;
✕. 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)
. 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.
✕. For female subjects: pregnant or lactating women.
✕. The patient has active tuberculosis, bacterial or fungal infection; There is HIV infection with active HBV infection, HCV infection.
✕. Those who have a history of psychotropic drug abuse and have mental disorders who cannot be remitted;
✕. 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).
✕. 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.