2023 ožujak:
Kratak sažetak:
The purpose of this clinical trial is to find out if anti-MESO antigen receptor Terapija T-stanicama CAR-a može be used to treat epithelial ovarian cancer that has come back or stopped responding to other treatments.
Detaljan opis:
Primarni ciljevi
To determine the feasibility and safety of anti-MESO CAR-T cells in treating patients with MESO-positive ovarian cancer.
Sekundarni ciljevi
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.
Studirati dizajn
Vrsta studije: Intervencijska (kliničko ispitivanje)
Predviđeni upis: 20 sudionika
Raspodjela: N/A
Model intervencije: Zadatak jedne grupe
Maskiranje: Nema (Open Label)
Primarna svrha: liječenje
Službeni naziv: Sigurnost i učinkovitost terapije MESO-CAR T stanicama za recidiv i refraktorni epitelni karcinom jajnika
Predviđeni datum početka studija: 20. travnja 2019
Predviđeni primarni datum završetka: 20. travnja 2022
Predviđeni datum završetka studije: 20. travnja 2023
Kriteriji
Kriteriji za uključivanje:
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.
Kriteriji za izuzeće:
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.
Provjerite popis bolnica koje rade CAR T-Cell terapija u Kini.
