Marts 2023:
Īss kopsavilkums:
The purpose of this clinical trial is to find out if anti-MESO antigen receptor CAR T-šūnu terapija var be used to treat epithelial ovarian cancer that has come back or stopped responding to other treatments.
Detalizēts apraksts:
Galvenie mērķi
To determine the feasibility and safety of anti-MESO CAR-T cells in treating patients with MESO-positive ovarian cancer.
Sekundārie mērķi
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.
Studiju plānojums
Pētījuma veids: intervences (klīniskais pētījums)
Paredzamais dalībnieku skaits: 20 dalībnieki
Piešķiršana: N/A
Intervences modelis: vienas grupas uzdevums
Maskēšana: nav (atvērta etiķete)
Galvenais mērķis: ārstēšana
Oficiālais nosaukums: MESO-CAR T šūnu terapijas drošība un efektivitāte recidivējoša un refraktāra epitēlija olnīcu vēža gadījumā
Paredzamais studiju sākuma datums: 20. gada 2019. aprīlis
Paredzamais primārās pabeigšanas datums: 20. gada 2022. aprīlis
Paredzamais studiju pabeigšanas datums: 20. gada 2023. aprīlis
Kritēriji
Iekļaušanas kritēriji:
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.
Izslēgšanas kritēriji:
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.
Pārbaudiet slimnīcu sarakstu CAR T-šūnu terapija Ķīnā.
