Pa Julayi 20, pulogalamu yatsopano yogwiritsira ntchito mankhwala(NDA) ya pCAR-19B yopangidwa payokha ndi Precision Biology idavomerezedwa mwalamulo ndi China National Medical Products Administration (NMPA). Mankhwalawa ndi mankhwala oyamba a CAR-T a khansa ya m'magazi ya ana ku China, omwe amagwiritsidwa ntchito pochiza odwala azaka zapakati pa 3-21 omwe ali ndi CD19-positive relapsed/refractory acute lymphoblastic leukemia (ALL).
Acute lymphoblastic leukemia (ALL) ndi imodzi mwa zotupa zoopsa kwambiri mwa ana komanso zomwe zimayambitsa imfa mwa ana ndi achinyamata. Chithandizo cha maselo a chimeric antigen receptor (CAR-T) chasintha kwambiri chithandizo cha relapse/refractory (R/R) B-cell ALL, ndi mankhwala oyamba ovomerezeka ndi FDA, Kymriah(tisagenlecleucel) opangidwa ndi Novartis, zomwe zathandiza kwambiri kuchepetsa kufooka kwa maselo komanso nthawi yopulumuka.
pCAR-19B ndi chinthu chopangidwa ndi maselo a CAR-T omwe ali ndi CD19-specific single-chain variable fragment (scFv) yokonzedwa kuti ithetse mavuto a chitetezo.
Mu Novembala 2023, pCAR-19B yapatsidwa "Chisankho cha Kuchiza Matenda Oyamba" ndi China National Medical Products Administration chifukwa chochiza B-ALL.
Zotsatira za mphamvu ndi chitetezo cha pCAR-19B mu mayeso ofunikira azachipatala okhudzana ndi ana aku China ndi odwala achichepere omwe ali ndi R/R B-cell ALLidalengezedwa paMsonkhano Wapachaka wa 66 wa American Society of Hematology (ASH).
Njira: Kuyesa kwa gawo lachiwiri (NCT05334823) kunali kafukufuku wa dzanja limodzi, wotseguka, komanso wa malo ambiri. Odwala azaka ≥ 3 ndi ≤ zaka 21 omwe adayesedwa ndi CD19+ R/R B-ALL yotsimikizika adaphatikizidwa. Mapeto ake akuluakulu anali kuchuluka kwa kukhululukidwa konse (ORR), komwe kumatanthauzidwa ngati kukhululukidwa kwathunthu (CR) kuphatikiza CR yokhala ndi kuchira kosakwanira kwa magazi (CRi) mkati mwa miyezi itatu atalandira chithandizo.
Zotsatira: Pofika pa Epulo 18, 2024, odwala 89 adalembedwa ndipo adachitidwa opaleshoni ya leukapheresis, ndipo odwala 64 adalandira pCAR-19B infusion. Panalibe milandu yolephera kupanga. Pakati pa odwala omwe adalowetsedwa, 6.25% (4/64) anali ofooka ndipo 93.75% (60/64) adabwereranso ku mitundu ingapo ya chithandizo chakale kapena kuikidwa kwa maselo oyambira a allogeneic. Zaka zapakati zinali zaka 11 (zaka 3-21), ndipo 56.25% (36/64) anali amuna. Kuphatikiza apo, 75% (48/64) mwa odwala anali ndi jini imodzi yoopsa kwambiri. Kulemera kwapakati kwa mafuta a m'mafupa (BM) blast blast pachiyambi kunali 58.3% (zaka 5%-98%) ndi kulemera kwakukulu kwa BM blast load (≥50%) komwe kunawonedwa mwa 56.25% ya odwala.
Pa nthawi yotsatila yapakati ya masiku 211 (35-750), ORR yabwino kwambiri inali 90.63% (58/64), ndipo 78.13% ya odwala (50/64) adapeza CR ndi 12.5% ya odwala (8/64) adapeza CRi, zomwe zidapambana mphamvu ya mankhwala oletsa CD19 CAR-T omwe adanenedwa mu R/R B-ALL. 98.27% (57/58) ya odwala omwe ali ndi ORR adapeza kuchira kwa matenda ochepa otsalira (MRD). ORR pa miyezi itatu inali 76.56% (49/64). Nthawi yapakati yoyankhira (DOR) inali miyezi 10.61 (95% nthawi yodzidalira 7.66-20.96). Nthawi yapakati yopulumuka (OS) inali miyezi 23.92 (95% nthawi yodzidalira 9.86-NR).
Matenda a Cytokine release syndrome (CRS) ndi immuno effector cell-associated neurotoxicity syndrome (ICANS) zinachitika mwa odwala 98.44% ndi 50% motsatana. Ma CRS a Giredi ≥3 ndi ICANS adawonedwa mwa odwala 29.69% ndi 39.06% motsatana. Nthawi yapakati ya ma CRS a Giredi ≥3 ndi ICANS inali masiku 4 ndi masiku atatu motsatana. Palibe imfa zomwe zidachitika chifukwa cha CRS kapena ICANS.
Mapeto: Ngakhale kuti pali kuphulika kwakukulu kwa BM komanso chiopsezo chachikulu cha kusintha kwa majini, pCAR-19B inasonyeza kuchuluka kwa kuchira kwabwino, inapeza kuchuluka kwa kuchira kwa MRD-negative, mayankho okhazikika, komanso mbiri yabwino yotetezeka. Kafukufukuyu akuyimira kuyesa koyamba kofunikira kwachipatala kwa ana a B-ALL mwa anthu aku Asia, kupereka njira yatsopano yothandizira ana aku China komanso odwala achichepere omwe ali ndi R/R B-ALL.
Pakadali pano, pali mayeso ena ambiri azachipatala a CAR-T ku China, ndipo akufunafuna odwala. Kuti mumve zambiri za mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
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Zolemba
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2. http://cq.news.cn/20240728/b0a74788930d4be7a45996be2808dd4f/c.html
4.https://ash.confex.com/ash/2024/webprogram/Paper206408.html
5.https://ashpublications.org/blood/article/140/Supplement%201/4625/491174/The-Safety-and-Efficacy-of-p-CAR-19B-a-Scfv
Nthawi yotumizira: Novembala-22-2024