March 2023:
Rudzi rweChidzidzo : Yekupindira (Clinical Trial)
Zvinofungidzirwa Kunyoresa: 30 vatori vechikamu
Kugoverwa: N/A
Kupindira Muenzaniso: Sequential Basa
Kupindira Muenzanisi Tsanangudzo: "3 + 3" dhizaini inoshandiswa kuona Maximum Tolerated Dose (MTD) uye yakakurudzirwa chikamu 2 dose (RP2D)
Masking: Hapana (Vhura Label)
Chinangwa Chekutanga: Kurapa
Musoro Wemutemo: Yakavhurika, Ruoko Rumwechete, Chikamu 1 Chidzidzo cheKuongorora Kuchengetedzeka / Kwekutanga Kushanda uye Kuona Iyo Maximal Yakatenderwa Dose yeB7-H3-yakanangana neCAR-T Cell Therapy muKurapa Recurrent Glioblastomas.
Zuva Rekutanga Kudzidza: Ndira 27, 2022
Zuva Rokupedzwa Kwekutanga : Zvita 31, 2024
Inofungidzirwa Zuva Rokupedzwa Kwekudzidza : Zvita 31, 2024
Dose-kuwedzera chikamu:
Iyo "3+3" dhizaini-yekuwedzera dhizaini inoshandiswa kuona MTD & R2PD. Anti-B7-H3 autologous CAR-T masero aipihwa kaviri vhiki nevhiki kuvarwere pamadosi anotevera ekutenderera kwega kwega, uye mitsetse ina sekosi imwe. Dose 4: 1 varwere pamutengo wemamiriyoni makumi maviri Masero kutenderera kwega kwega. Dose 2: 3 varwere pamwero we60 miriyoni Masero kutenderera kwega kwega. Dose 3: 3 varwere pamwero we150 miriyoni Masero kutenderera kwega kwega. Dose 4: 3 varwere pamwero we450 miriyoni Masero kutenderera kwega kwega. Dose 5: 3 varwere pamwero we900 miriyoni Masero kutenderera kwega kwega.
R2PD yekusimbisa chikamu:
Sarudza iyo R2PD zvichienderana nemhedzisiro kubva kune yapfuura dose-yekuwedzera kudzidza; Rapa vamwe varwere gumi nevaviri vane anti-B12-H7 autologous CAR-T masero biweekly paR2PD kuti uwedzere kusimbisa kuchengetedzwa kweR2PD.
Pachikamu chega chega, kana varwere vachiratidza kushivirira uye kupindura kune mabatiro, varwere ava vaizowana zvidzidzo zvakawanda zve mabatiro pakufunga kwePI.
Zvikonzero
Kuisirwa maitiro
- Murume kana mukadzi, ane makore 18-75 makore (kusanganisira 18 uye 75 makore)
- Varwere vane kudzokazve glioblastoma, sekusimbiswa ne positron emission tomography (PET) kana histologic pathology.
- A >= 30% staining extent of B7-H3 in his/her primary/recurrent tumarara tissue by the immunochemical method;
- Karnofsky chikero chikero> = 50
- Kuwanikwa mukuunganidza peripheral blood mononuclear cells (PBMCs)
- Zvakakwana marabhoritari tsika uye yakakwana nhengo basa;
- Varwere vane mukana wekubereka/kubereka vanofanira kubvuma kushandisa nzira dzekudzivirira nadzo kubata pamuviri.
Kudzinga maitiro
- Vakadzi vane pamuviri kana vanoyamwisa
- Contraindication to bevacizumab
- Mukati memazuva mashanu isati yasvika CAR-T cell infusion, vanhu vanogamuchira systemic administration ye steroid ine dosage yakakura kudarika 5mg/d prednisone kana madosi akaenzana emamwe steroid (kwete kusanganisira inhaled corticosteroid)
- Comorbid with Other uncontrolled malignancies
- Active immunodeficiency virus (HIV), utachiona hwehepatitis B, utachiona hwehepatitis C kana chirwere chetachiona;
- Subjects receiving the placement of a carmustine slow-release wafer within 6 months before the enrollment;
- Autoimmune zvirwere;
- Kugamuchira kwenguva refu immunosuppressive kurapwa mushure mekugadzirisa nhengo;
- Zvirwere zvakakomba kana zvisingadzoreki zvepfungwa kana mamiriro anogona kuwedzera zviitiko zvakashata kana kukanganisa kuongororwa kwemhedzisiro;
- Kwete kupora kubva kune chepfu kana mhedzisiro nekurapa kwekare;
- Vadzidzi vakapinda mune imwe muedzo wekupindira mukati memwedzi mumwe vasati vanyoresa, kana kuti vakagamuchira mamwe CAR-T cell therapies kana gene-modified cell therapy vasati vanyoresa.
- Zvidzidzo zvine mamiriro ekurapa anokanganisa kusaina chibvumirano chakanyorwa chine ruzivo kana kutevedzera maitiro ekutsvagisa, anosanganisira, asi asina kuganhurirwa, cardio-cerebral vascular zvirwere, renal dysfunction / kutadza, pulmonary embolism, coagulation kusagadzikana, inoshanda systemic hutachiona, hutachiona husingadzoreki, et. . al., kana varwere vasingade kana kusakwanisa kutevedzera maitiro ekutsvagisa;
- Zvidzidzo zvine mamwe mamiriro angazokanganisa kubatanidzwa kwekutongwa pakufunga kwemuongorori.
