Anti-BCMA CAR T-Cell kurapa kwekiriniki miedzo yekudzokazve/refractory Immune thrombocytopenia(R/R ITP)

Iyi inotarisirwa, imwe-pakati, yakavhurika-label, kudzidza-ruoko-rumwechete, kuongorora kushanda uye kuchengetedzwa kweAnti-BCMA chimeric antigen receptor T cell therapy (BCMA CAR-T) kune varwere vane kudzokazve / refractory Immune thrombocytopenia (R. /R ITP).

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Kurume 2023: Immune thrombocytopenia (ITP) chirwere chinogona kutungamira kune nyore kana kuwandisa maronda uye kubuda ropa. Vanosvika zvikamu zviviri kubva muzvitatu zvevarwere vanowana kuregererwa mushure / panguva yekurapa kwekutanga. Nekudaro, chimwe chikamu chevarwere hachina kugona kuwana kuregererwa kwenguva refu kana kutomboramba kurapwa kwekutanga. Zviitiko izvozvo, zvinozivikanwa serelapse/refractory Immune thrombocytopenia (R/R ITP), inotakura mutoro unorema wechirwere unodzikisira hupenyu hwehupenyu. Mazhinji ezvirwere zvinotora chikamu mukuitika kweR / R ITP, uye inonyanya kukosha yadzo ndeye antibody-mediated immune platelet kuparadzwa. Sekuzivikanwa kwazvinoitwa, masoja emuviri eplatelet emunhu anonyanya kuvharirwa nemasero eplasma, kunyanya masero eplasma anogara kwenguva refu. Vatsvakurudzi vanoda kuongorora izvo zvinogona BCMA CAR-T kubatsira R/R ITP varwere kuwedzera platelet count, kuderedza kubuda ropa episodhi uye dose yemishonga inopindirana.

Kuedza: Anti-BCMA CAR T-masero infusion R/R ITP varwere vanogamuchira infusion ye autologous anti-BCMA CAR T-masero nehuwandu hwe1.0-2.0×10e7/Kg. Varwere vanozotevera kwemwedzi mitanhatu mushure CAR T-cell therapy.

Biological: autologous anti-BCMA chimeric antigen receptor T masero

Lymphoadenodepletion chemotherapy ne FC (fludarabine 30mg/ m2 kwemazuva matatu akatevedzana uye cyclophosphamide 3mg/m300 kwemazuva matatu akatevedzana) ichapiwa pazuva -2, -3 uye -5 zvisati zvaitika. CAR T-masero infusion. Zvose zve 1.0-2.0 × 10e7/Kg autologous anti-BCMA CAR T-masero ichaiswa nedosi-kukwira mushure me lymphoadenodepletion chemotherapy. Dose of CAR T-masero are allowed to be adjusted according to the severity of cytokine release syndrome.

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Inosanganisira Maitiro:

  • Refractory ITP inotsanangurwa zvinoenderana neazvino maitiro ekubvumirana ('Chinese gwara pamusoro pekuongororwa uye manejimendi evakuru ekutanga immune thrombocytopenia (version 2020)'), kana kudzokazve ITP inotsanangurwa sevarwere veITP vakapindura kune yekutanga-mutsara therapy (glucocorticoids kana immunoglobulins) uye anti-CD20 monoclonal antibody, asi haigone kuchengetedza mhinduro.
  • Makore 18-65 makore akabatanidzwa.
  • Yakakwana venous kuwana apheresis kana venous ropa uye hapana zvimwe contraindications kuti leukocytosis.
  • Eastern Cooperative Oncology Group (ECOG) maitiro ekuita kwe0-2.
  • Zvidzidzo zvinofanirwa kuve nekugona kwakazara kwemaitiro ehurumende, kunzwisisa ruzivo rwakakosha, kusaina fomu remvumo nekuzvidira, uye kuve nemubatanidzwa wakanaka nezviri muprotocol yetsvagiridzo.

Kuregererwa Criteria:

  • Sekondari ITP.
  • Varwere vane nhoroondo inozivikanwa kana kuongororwa kwekutanga kwe arterial thrombosis (yakadai secerebral thrombosis, myocardial infarction, nezvimwewo), kana comorbidity yevenous thrombosis (yakadzika vein thrombosis, pulmonary embolism), kana vari kushandisa anticoagulant/antiplatelet drug pakutanga. yekutongwa.
  • Varwere vane nhoroondo inozivikanwa kana kuongororwa kwekare kwechirwere chemoyo chemoyo.
  • Varwere vane hutachiona husingadzoreki, kusashanda kwenhengo kana chero kusadzora kusingadzoreki kunoshanda chirwere chinotadzisa kutora chikamu sezvakatsanangurwa.
  • Varwere vane hutsinye kana nhoroondo yekurwara.
  • Yakundikana kuedza kuwedzera masero eT.
  • Panguva yekuongorora, hemoglobin <100g/L; kukosha kwakakwana kweutrophil count <1.5×10^9/L.
  • Panguva yekuongorora, serum creatinine concentration> 1.5x yepamusoro yepamusoro yehuwandu hwehuwandu, huwandu hwebilirubin> 1.5x muganhu wepamusoro wehuwandu hwemazuva ose, alanine aminotransferase uye aspartate aminotransferase> 3x muganhu wepamusoro wehuwandu hwemazuva ose, Kuruboshwe ventricular ejection fraction ≤ 50% ne echocardiography, Pulmonary function ≥ giredhi 1 dyspnea (CTCAE v5.0), ropa reoxygen saturation <91% pasina oxygen inhalation.
  • Prothrombin nguva (PT) kana prothrombin nguva-yepasi rose normalized ratio (PT-INR) kana activated partial thromboplastin time (APTT) inopfuura 20% yehuwandu hwehuwandu hwemashoko; kana nhoroondo ye coagulation abnormalities kunze kweITP.
  • Masoja ekudzivirira HIV kana syphilis ari positive; hepatitis C antibody yakanaka uye kuonekwa kweHCV-RNA kunodarika laboratory test yepamusoro yereferensi; Hepatitis B surface antigen yakanaka uye kuonekwa kweHBV-DNA kunodarika bvunzo dzemurabhoritari yepamusoro yereferensi.
  • Akatora chikamu mune zvimwe zvidzidzo zvekiriniki mukati memwedzi ye3 isati yasvika iyi CAR-T cell infusion.
  • Varwere vane pamuviri kana kuyamwisa, kana kuronga pamuviri.
  • Varwere vane mbereko uye muongorori anoona kuti nyaya yacho haina kufanira kutora chikamu.
  • Nhoroondo yekusawirirana kwezvinodhaka zvakanyanya kana inozivikanwa allergy kune CAR-T mishonga ine chekuita nemishonga.
  • Kufungidzirwa kana kusimbiswa doro, zvinodhaka kana kushandisa zvinodhaka.
  • Muongorori anotonga kuti hazvina kukodzera kutora chikamu mukutongwa uku.

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