Marzec 2023:
Krótkie podsumowanie:
The purpose of this clinical trial is to find out if anti-MESO antigen receptor Terapia limfocytami T CAR mogą be used to treat epithelial ovarian cancer that has come back or stopped responding to other treatments.
Szczegółowy opis:
Cele podstawowe
To determine the feasibility and safety of anti-MESO CAR-T cells in treating patients with MESO-positive ovarian cancer.
Cele drugorzędne
To assess the efficacy of anti-MESO CAR-T cells in patients with ovarian cancer.
To determine the in vivo dynamics and persistency of anti-MESO CAR-T cells.
Projekt badania
Rodzaj badania: Interwencyjne (badanie kliniczne)
Szacowana liczba uczestników: 20 uczestników
Alokacja: nie dotyczy
Model interwencji: przydział do jednej grupy
Maskowanie: brak (otwarta etykieta)
Główny cel: leczenie
Oficjalny tytuł: Bezpieczeństwo i skuteczność terapii komórkami T MESO-CAR w nawrotowym i opornym na leczenie nabłonkowym raku jajnika
Szacowana data rozpoczęcia badania: 20 kwietnia 2019 r
Szacowana data ukończenia podstawowego: 20 kwietnia 2022 r
Przewidywana data zakończenia badania: 20 kwietnia 2023 r
kryteria
Kryteria przyjęcia:
18 to 70 Years Old, female; Expected survival > 12 weeks; Clinical performance status of ECOG score 0–2; Patients who have previously been treated with second-line or more lines of standard treatment are not effective (No remission or recurrence after remission); At least one measurable tumor foci according to RECIST standard 1.1 ; Positive Mesothelin expression in tumor tissues; Creatinine ≤ 1.5×ULN; ALT and AST ≤ 3×ULN; Total bilirubin ≤ 2×ULN; Hemoglobin≥90g/L; Absolute counting of neutrophils≥1000uL ; Absolute counting of lymphocytes>0.7×10^9/L; Counting of Platelets≥75000/uL; The venous access required for collection can be established without contraindications for leukocyte collection. I am able to understand and sign the informed consent document.
Kryteria wyłączenia:
Accompanied by other uncontrolled malignant tumors; Active hepatitis B, hepatitis C, syphilis, HIV infection; Suffering severe cardiovascular or respiratory disease; Any other diseases could affect the outcome of this trial. Any affairs that could affect the safety of the subjects or outcome of this trial Pregnant or lactating women, or patients who plan to be pregnant during or after treatment; There are active or uncontrollable infections (except simple urinary tract infections or upper respiratory tract infections) that require systemic therapy 14 days or 14 days prior to assignment; Patients who are accounted by researchers as not appropriate for this test; Received CAR-T treatment or other gene therapies before assignment; Subject suffering disease affects the understanding of informed consent or compliance with study protocol.
Sprawdź listę szpitali robi Terapia CAR T-Cell w Chinach.
