Lapaʻau CAR-T no ke Kanesa ʻōpū

ʻO Claudin18.2 (CLDN18.2) kahi isoform protein tight junction i hōʻike kikoʻī ʻia i loko o ka epithelium gastric a ua hoʻonui nui ʻia ma luna o ka ʻili o nā cell cancer gastric. ʻO CT041 (code development CG4006) kahi huahana CAR-T autologous e kuhikuhi ana iā CLDN18.2. Hōʻike ka ʻikepili Phase I i ka hana anti-tumor i nā poʻe maʻi kanesa gastric CLDN18.2-positive i mālama mua ʻia.

ʻIke ʻia hoʻi ka hoʻonui nui ʻia ʻana o HER2 i loko o kahi hui o nā maʻi kanesa ʻōpū. Ua hōʻike nā lāʻau lapaʻau CAR-T i hoʻopaʻa ʻia me HER2 i ka hiki ke anti-tumor i nā haʻawina preclinical a me nā haʻawina lapaʻau mua. Aia ʻo Triumvira Immunologics' TAC01-HER2 i nā hoʻokolohua lapaʻau Phase II i kēia manawa.

• Ka Hoʻolālā Kikoʻī LoaMa ke kuhikuhi ʻana i nā pūnaewele CAR-T e kūʻē i ka CLDN18.2 a i ʻole HER2, hiki ke ʻike pololei ʻia a hoʻopau ʻia nā pūnaewele kanesa ʻōpū, e hōʻemi ana i nā hopena ma waho o ka puʻupuʻu.

• Ke lanakila nei i ke kū'ē ʻana o ka lāʻau MultilineMa nā hoʻokolohua CT041, ua hoʻokō ka hui maʻi ʻōpū i kahi helu pane pahuhopu (ORR) o 57.1%, ka helu kaohi maʻi (DCR) o 75.0%, a me ke ola holoʻokoʻa 6 mahina (OS) o 81.2% i nā poʻe maʻi i hāʻule i nā laina lapaʻau he nui ma mua.

• Nā Pane PaʻaUa hua mai ka mālama ʻana o CLDN18.2-CAR-T i kahi manawa pane o 6 mahina o 44.8%, e hōʻike ana i ka hiki ke loaʻa ka pōmaikaʻi lapaʻau lōʻihi.

• Hoʻōla pilikinoʻO ka hoʻohana ʻana i nā pūnaewele T ponoʻī o ka mea maʻi e hōʻemi i ka pilikia o ka hōʻole ʻia a hoʻonui i ka palekana a me ka pono.

• Hōʻiliʻili Kelepona T Koko Peripheral
  Ua hoʻokaʻawale ʻia nā pūnaewele T mai ke koko peripheral o ka mea maʻi ma o ka leukapheresis.

• ʻEnekinia Genetic
  I loko o kahi keʻena hoʻokolohua e kūlike ana me GMP, ua hoʻololi ʻia nā pūnaewele T e hōʻike i kahi CAR e kuhikuhi ana iā CLDN18.2 a i ʻole HER2, a laila hoʻonui ʻia ex vivo.

• Hoʻomaʻamaʻa Lymphodepleting
  Hoʻokele ʻia kahi papa hana hoʻomākaukau o cyclophosphamide a me fludarabine e hoʻopau i nā lymphocytes endogenous a hana i kahi niche kūpono no ka hoʻonui ʻana o nā cell CAR-T.

• Hoʻokomo ʻana o ke kelepona CAR-T
  Hoʻihoʻi ʻia nā pūnaewele CAR-T i hana ʻia i loko o ka mea maʻi ma o ka intravenous.

• Ka Nānā ʻana a me ka Hoʻokele ʻana
  Ma hope o ka hoʻokomo ʻia ʻana o ka infusion, nānā pono ʻia nā maʻi no ka cytokine release syndrome (CRS) a me ka neurotoxicity, me nā hana kūpono i ka manawa e like me ka mea e pono ai.

• Ka Loiloi Kuikahi o ka Pae I CT041 (CLDN18.2-CAR-T)
  Ma waena o 37 mau maʻi i mālama nui ʻia, ua loaʻa i ka hui maʻi ʻōpū ka ORR 57.1%, DCR 75.0%; 94.6% i ʻike wale i ka Papa 1-2 CRS, me ka ʻole o ka Papa 3 a ʻoi aku paha CRS a i ʻole neurotoxicity; ʻO ka lōʻihi o 6 mahina o ka pane he 44.8%.

• Nā hopena hope loa o ka pae I o Satri-cel (e kuhikuhi pū ana iā CLDN18.2)
  I loko o 98 mau maʻi kanesa gastrointestinal CLDN18.2-positive, ʻo ORR he 38.8%, DCR 91.8%; ʻo ka median progression-free survival (mPFS) he 4.4 mahina (95% CI 3.7–6.6), ʻo ka median overall survival (mOS) 8.8 mahina (95% CI 7.1–10.2); 96.9% i ʻike wale i ka Grade 1–2 CRS, me ka ʻole o ka Grade 3+ CRS a i ʻole nā ​​make e pili ana.

• ʻIkepili Lapaʻau Mua HER2-CAR-T
  Ua hōʻike ke aʻo mua ʻana o ka Pae I i ke kanaka i kahi ʻano palekana e hiki ke hoʻokele ʻia; ke hoʻomau nei kahi hoʻokolohua hoʻopaʻa inoa Pae II.

• Kahua ʻenehana alakaʻi
  Hoʻokele ʻo BIOOCUS i kahi hale hana lapaʻau cell GMP-grade honua, e hōʻoiaʻiʻo ana i ka hana ʻana o nā cell CAR-T kūpono a kūlike.

• Hui Loea Multidisciplinary
  Aia i loko o kā mākou hui nā loea akamai i ka immunology, oncology, a me ka cell therapy, e hāʻawi ana i ka hoʻokele pilikino piha.

• ʻIke Lapaʻau Honua
  Ua mālama mākou i nā maʻi mai nā wahi a puni o ka honua, e hōʻiliʻili ana i ka ʻikepili nui no ka palekana a me ka pono.

• Ka lawelawe piha a hiki i ka hopena
  Mai ka hoʻolālā protocol a me ka hoʻonohonoho ʻana i ka mālama ʻana ma waho o ka ʻāina a hiki i ka hahai ʻana ma hope o ka hoʻopili ʻana i ka lāʻau lapaʻau i ka wā lōʻihi, hāʻawi ʻo BIOOCUS i ke kākoʻo hoʻokahi.