Ruzivo Ruzere:
Ichi chidzidzo chepakati, ruoko rumwe, chidzidzo chakavhurika. Mushure mekusangana nemaitiro ekukodzera uye kunyoresa pakutongwa, varwere vanozosangana neleukapheresis yekuunganidza autologous lymphocytes. Kana maseru angogadzirwa, varwere vanozoenderera mberi kune lymphodepleting chemotherapy ne cyclophosphamide uye fludarabine kwemazuva 1-2 akatevedzana achiteverwa nekuisirwa kweCAR T-masero padanho rakanangwa re3-10 × 105 maseru/kg.
Zvikonzero
Inosanganisira Maitiro:
- CD19-positive isiri-Hodgkin lymphoma yakasimbiswa ne cytology kana histology maererano neWHO2016 maitiro:
- Kuparadzira B-cell lymphoma yakakura: kusanganisira isina kutaurwa (DLBCL, NOS), kusingaperi kuzvimba-kwakabatana DLBCL, primary cutaneous DLBCL (gumbo rudzi), EBV-positive DLBCL (NOS); uye yakakwirira-giredhi B-cell lymphoma (kusanganisira yepamusoro-giredhi B-cell lymphoma, NOS, uye yepamusoro-giredhi B-cell lymphoma ine MYC uye BCL2 uye / kana BCL6 rearrangements); uye primary mediastinal hombe B-cell lymphoma; uye T-cell-rich histiocytosis B-cell lymphoma; uye yakashandurwa DLBCL (yakadai sefollicular lymphoma, chronic lymphocytic leukemia / duku B-lymphocytic lymphoma yakashandurwa DLBCL); varwere vane zviri pamusoro tumarara mhando dzakabatwa neinenge yekutanga-uye yechipiri-mutsara zvinodhaka uye ine chirwere chakagadzikana kwe ≤12 mwedzi, kana apo yakanakisa Chirwere kufambira mberi mushure mekuita; kana kufambira mberi kwechirwere kana kudzoka shure mushure me autologous stem cell transplantation ≤12 mwedzi;
- Maererano ne WHO2016 maitiro cytology kana histology yakasimbisa CD19 yakanaka: follicular cell lymphoma. Varwere vane rudzi urwu rwebundu vakagamuchira kanenge kechitatu-mutsara kurapwa, uye kudzokorora kana kukura kwechirwere kwakaitika mukati memakore maviri mushure mekurapa kwemutsara wechitatu kana kupfuura. Parizvino mukufambira mberi kwechirwere, chirwere chakagadzikana, kana kuregererwa kwechikamu;
- Zvinoenderana neWHO2016 yakajairwa cytology kana histology yakasimbisa CD19 yakanaka: jasi cell lymphoma. Varwere vakadaro havana kuporeswa kana kudzoka shure mushure mekurapa kwemitsara mitatu uye havakodzeri stem cell transplantation kana kudzoka zvakare mushure mekutaridzirwa kwe stem cell;
- Zera ≥18 makore (kusanganisira chikumbaridzo);
- Maererano neshanduro ye2014 yeLugano maitiro, pane zvishoma zviviri-maviri-dimensional chiyero chekuyera senheyo yekuongorora: kune intranodal maronda, inotsanangurwa se: kureba kureba> 1.5cm; kune extranodal maronda, kureba kureba kunofanira kuva> 1.0cm;
- Eastern Cooperative Oncology Boka chiitiko chimiro cheECOG mamakisi 0-2;
- Kuwana venous kunodiwa kuunganidzwa kunogona kusimbiswa, uye kune masero akakwana akaunganidzwa neasina-mobilized apheresis yeCAR-T cell production;
- Chiropa uye itsvo basa, cardiopulmonary function inosangana nezvinodiwa zvinotevera:
- Serum creatinine≤2.0×ULN;
- Kuruboshwe ventricular ejection chikamu ≥ 50% uye hapana pachena pericardial effusion, hapana ECG isina kujairika;
- Ropa okisijeni saturation ≥92% mune isiri-okisijeni mamiriro;
- Ropa rose bilirubin≤2.0×ULN (kunze kwekunge pasina kukosha kwekliniki);
- ALT uye AST≤3.0 × ULN (ine chiropa tumor infiltration≤5.0 × ULN);
- Iva nekugona kunzwisisa uye nekuzvidira kusaina chibvumirano chine ruzivo.
Kuregererwa Criteria:
- Yakagamuchira CAR-T therapy kana imwe gene-modified cell therapy isati yaongororwa;
- Yakagamuchira anti-tumor therapy (kunze kwe systemic immune checkpoint inhibition kana stimulation therapy) mukati memavhiki maviri kana 2 hafu yeupenyu (chero ipfupi) isati yaongororwa. 5 hafu-hupenyu hunodiwa kunyoresa (semuenzaniso, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX3 receptor agonist, 40-4BB receptor agonist, nezvimwewo);
- Avo vakagamuchira hematopoietic stem cell transplantation (ASCT) mukati memavhiki e12 vasati vasvika apheresis, kana avo vakambogamuchira allogeneic hematopoietic stem cell transplantation (HSCT), kana avo vane nhengo yakasimba yekushandura; immunosuppression inodikanwa mukati memavhiki maviri pamberi peapheresis Giredhi 2 uye pamusoro peGVHD yemushonga;
- Varwere vane atrial kana ventricular lymphoma kubatanidzwa kana vanoda kurapwa kwekukurumidzira nekuda kwebundu guru rakadai sekuvhara mumatumbo kana vascular compression;
- Wakabayiwa nhomba yekudzivirira yekurarama mukati memavhiki matanhatu tisati tabvisa maperembudzi;
- Cerebrovascular tsaona kana pfari yakaitika mukati memwedzi mitanhatu isati yasaina ICF;
- Nhoroondo yemyocardial infarction, cardiac bypass kana stent, angina isina kugadzikana kana imwe kliniki inokosha yemwoyo chirwere mukati memwedzi ye12 isati yasaina ICF;
- Zvirwere zveautoimmune zvinoshanda kana zvisingadzoreki (zvakadai sechirwere cheCrohn, rheumatoid arthritis, systemic lupus erythematosus), kunze kweavo vasingadi kurapwa kwehurongwa;
- Mamota akashata kunze kweasiri-Hodgkin lymphoma mukati memakore mashanu asati aongororwa, kunze kwekunyatsorapwa cervical carcinoma in situ, basal cell kana squamous cell cancer yeganda, kenza yeprostate yemuno mushure mekurasika resection, Ductal carcinoma in situ;
- Chirwere chisingadzoreki mukati mevhiki 1 isati yaongororwa;
- Hepatitis B surface antigen (HBsAg) kana hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer inowanikwa yakakura kudarika yakajairika referensi; kana hepatitis C virus (HCV) antibody positive uye peripheral blood C Hepatitis virus (HCV) RNA titer test yakakura kudarika inowanzoitika; kana hutachiwana hwehutachiona hweHIV (HIV) antibody positive; kana syphilis test positive; cytomegalovirus (CMV) DNA test positive;
- Vakadzi vane pamuviri kana vanoyamwisa; kana vakadzi vezera rekubereka vane bvunzo yakanaka yekuzvitakura panguva yekuongororwa; kana varwere vechirume kana vechikadzi vasingade kushandisa kudzivirira kubata pamuviri kubva panguva yekusaina fomu remvumo ine ruzivo kusvika gore 1 mushure mekugamuchira CAR-T cell infusion;
- Vamwe vaongorori vanoona zvisina kukodzera kutora chikamu muchidzidzo.
