Satricabtagene autoleucel (Satri-cel, CT041)

satricabtagene autoleucel（Satri-cel,CT041) wani samfurin ƙwayoyin T-cell ne na CAR wanda ke da ikon zama na farko a duniya. Satri-cel yana kai hari ga ƙwayoyin cuta masu ƙarfi na Claudin18.2 waɗanda ke da babban fifiko ga ciwon daji na ciki/ciwon gastroesophageal junction (GC/GEJ) da ciwon daji na pancreas (PC).

An buga sakamakon ƙarshe na gwajin da mai binciken ya fara yi wa satriccabtagene autoleucel a cikin Nature Medicine a ranar 3 ga Yuni, 2024.

Jimillar marasa lafiya 98 ne suka shiga gwajin, kuma sakamakon ya nuna cewa adadin rage radadin cutar (DCR) ya kai kashi 91.8%, marasa lafiya 38 sun sami sassauci, jimillar adadin ya rage radadin cutar shine kashi 38.8%, matsakaicin rayuwa ba tare da ci gaba ba (PFS) shine watanni 4.4, matsakaicin rayuwa (OS) shine watanni 8.8, kuma matsakaicin tsawon lokacin da za a yi wa mutum gafara (mDOR) shine watanni 6.4. Daga cikin marasa lafiya 90 da aka yi wa tiyatar, marasa lafiya 70 sun sami matakai daban-daban na raguwar ciwon daji.

Daga cikin marasa lafiya 51 da aka yi wa magani da maganin ciwon ciki da Satri-cel, adadin maganin da aka yi wa magani ya kai kashi 96.1% (49), kuma jimillar adadin maganin da aka yi masa ya kai kashi 54.9% (28). Daga cikinsu, marasa lafiya 27 sun sami sassaucin amsawa (PR), majiyyaci 1 ya sami cikakken amsawa (CR), kuma matsakaicin tsawon lokacin amsawa (mDOR) shine watanni 6.4.

Kammalawa

Satri-cel yana nuna yuwuwar warkewa tare da bayanin aminci mai sarrafawa ga marasa lafiya da ke fama da cutar kansar ciki mai ci gaba ta CLDN18.2.

A ranar 9 ga Satumba, 2023, an buga shari'o'i biyu na maganin cutar kansar pancreas tare da CARsgen's CT041, wani sabon maganin Claudin (CLDN) 18.2 CAR T-cell Therapy, a cikin Journal of Hematology & Oncology mai taken "Maganin ƙwayoyin CAR T na CT041 don cutar kansar pancreas mai kama da ta Claudin18.2".

Ga shari'a ta 1, an gano wata mace mai shekaru 58 tana da ciwon daji na pancreas tare da metastasis na ƙwayoyin huhu da lymph nodes. An kasa samun maganin nab-paclitaxel na farko da gemcitabine da irinotecan-liposome na biyu da 5-flurouracil kafin a yi mata gwajin asibiti na CT041, bayan an tabbatar da cewa CLDN18.2 yana nuna 2+/70%. Bayan an cire ƙwayoyin lymph wanda ya ƙunshi fludarabine, cyclophosphamide, da nab-paclitaxel, an ba da maganin CT041 na 250 × 10.⁶An ba wa majiyyacin ƙwayoyin halitta a watan Satumba na 2021. An sami ciwon sakin cytokine na aji na 2 (CRS), wanda daga baya aka sarrafa shi ta hanyar tocilizumab. An sami martanin ɓangare (PR) bisa ga RECIST v1.1, tare da raguwar yawan fashewar huhu.

Ga shari'a ta 2, an gano wata mata mai shekaru 75 tana da cutar kansar pancreas ta pT2N0 bayan an yi mata tiyata a watan Mayu na 2019. An gano cutar huhu bayan watanni 5 a lokacin bin diddigin tiyatar bayan tiyata. An ba da maganin S-1 na farko a matsayin maganin chemotherapy na farko tun daga Disamba 2019. A lokacin aikin tiyatar radiation na palliative, an lura da ci gaban ciwon daji a cikin huhu. Tunda an tantance yanayin CLDN18.2 a matsayin 3+/60%, an yi wa majiyyacin gwajin asibiti na CT041. Bayan an sami lymphodepletion wanda ya ƙunshi fludarabine, cyclophosphamide da nab-paclitaxel, an ba majiyyacin maganin CT041 na 250 × 10.⁶Kwayoyin halitta a watan Yulin 2021. Marasa lafiya sun sami CRS na aji na 2, wanda aka ƙara sarrafa shi da tocilizumab. An cimma nasarar PR tun bayan gwajin farko makonni 4 bayan allurar. Daga baya raunukan da aka samu na cutar huhu suka ɓace kuma suka sami cikakken amsa. Har yanzu ciwon yana ƙarƙashin kulawa mai kyau har zuwa lokacin da aka sake duba shi a watan Yulin 2023. Lambar kwafin jinin gefe na CLDN18.2 CAR a cikin marasa lafiya biyu ta nuna ƙaruwa cikin sauri bayan allurar, wanda ya kai kololuwa cikin makonni 2. A lokaci guda, sakamakon rarraba ƙwayoyin halitta da aka kunna ta hanyar haske ya nuna ƙaruwa a cikin ƙwayoyin T na CD8 da ƙwayoyin Treg na jini, tare da raguwa a cikin ƙwayoyin T na CD4 da ƙwayoyin B. Waɗannan canje-canje a cikin nau'ikan ƙwayoyin garkuwar jiki sun nuna juriya mafi girma idan aka kwatanta da canje-canje a matakan cytokine.

A halin yanzu, akwai wasu gwaje-gwajen asibiti da yawa na CAR-T a China, kuma suna neman marasa lafiya. Don neman shawara kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Kasa da Kasa na Asibitin Oncology na Yankin Kudu na Beijing.

Lambar Waya: 4008803716

Imel:myimmnet@163.com

Nassoshi

1.https://www.carsgen.com/en/news/carsgen-presents-updated-results-on-satri-cel-in-nature-medicine-and-at-2024-asco/

2.https://www.nature.com/articles/s41591-024-03037-z

3.https://www.carsgen.com/media/fooloi3a/ct041-cg4006-asco-2024_v3-0_20240603.pdf

4.https://jhoonline.biomedcentral.com/articles/10.1186/s13045-023-01491-9