satricabtagene autoleucel （Satri-cel, CT041)

Satricabtagene autoleucel (Satri-cel, CT041) ni ubwoko bwa selile za CAR T zikomoka ku bwoko bwa autologous zirwanya poroteyine ya Claudin18.2 ishobora kuba iya mbere ku isi. Satri-cel yibasira ibibyimba bikomeye bya Claudin18.2, ikaba yibasira cyane kanseri y'igifu/kanseri y'agahu k'umuyoboro w'amaraso (GC/GEJ) na kanseri ya pancreas (PC).

Ibisubizo bya nyuma by’ikurikirana ry’igeragezwa ryatangijwe n’umushakashatsi CT041-CG4006 (NCT03874897) rya satricabtagene autoleucel byasohotse mu kinyamakuru Nature Medicine ku ya 3 Kamena 2024.

Abarwayi 98 bitabiriye igerageza, kandi ibyavuye mu bushakashatsi byagaragaje ko igipimo cyo kurwanya indwara (DCR) cyari hejuru kigera kuri 91.8%, abarwayi 38 bakize, igipimo cyo kuruhuka muri rusange cyari 38.8%, ikigereranyo cyo kubaho nta guhindagurika (PFS) cyari amezi 4.4, ikigereranyo cyo kubaho muri rusange (OS) cyari amezi 8.8, naho ikigereranyo cyo kuruhuka (mDOR) cyari amezi 6.4. Mu barwayi 90 b’ibanze b’ibisebe, abarwayi 70 bakize ku rugero rutandukanye rw’ibibyimba.

Mu barwayi 51 ba kanseri y'igifu bavuwe hakoreshejwe uburyo bumwe bwo kuvura Satri-cel, igipimo cyo kurwanya indwara cyari hejuru cyane kigera kuri 96.1% (49), naho igipimo rusange cyo gusubiza cyari 54.9% (28). Muri bo, abarwayi 27 babonye igisubizo cy'igice (PR), umurwayi 1 yabonye igisubizo cyuzuye (CR), naho igihe cyo gusubiza (mDOR) cyari amezi 6.4.

Umwanzuro

Satri-cel igaragaza ubushobozi bwo kuvura hamwe n'umutekano uhamye ku barwayi barwaye kanseri y'igifu ya CLDN18.2.

Ku ya 9 Nzeri 2023, hasohotse inkuru ebyiri z’ubuvuzi bwa kanseri ya pancreas iterwa na CARsgen's CT041, uburyo bushya bwo kuvura bwa Claudin (CLDN) 18.2 CAR T-cell Therapy, mu kinyamakuru Journal of Hematology & Oncology cyitwa “CT041 CAR T cell therapy for Claudin18.2 positive metastatic pancreas cancer”.

Ku rubanza rwa 1, umugore w'imyaka 58 yasuzumwe kanseri y'indurwe iterwa n'ibihaha n'uturemangingo tw'imitsi. Indwara ya nab-paclitaxel yo ku rwego rwa mbere hamwe na gemcitabine hamwe na irinotecan-liposome yo ku rwego rwa kabiri hamwe na 5-flurouracil byarananiranye mbere yuko yinjizwa mu igeragezwa rya CT041, nyuma yo kwemeza ko CLDN18.2 yagaragaye kuri 2+/70%. Nyuma yo kugabanya ubukana bw'imitsi igizwe na fludarabine, cyclophosphamide, na nab-paclitaxel, dose ya CT041 ya 250 × 10.⁶Uturemangingo twahawe umurwayi muri Nzeri 2021. Indwara yo gusohora cytokine mu cyiciro cya kabiri (CRS) yabayeho, nyuma iza kugenzurwa na tocilizumab. Uburyo bwo gusubiza igice (PR) bwagezweho hakurikijwe RECIST v1.1, butuma ibihaha bigabanuka cyane.

Ku kibazo cya 2, umugore w'imyaka 75 yasuzumwe ko ari kanseri ya pT2N0 pancreas nyuma yo kubagwa muri Gicurasi 2019. Yavumbuwe nyuma y'amezi 5 mu gihe cyo gukurikirana nyuma yo kubagwa. S-1 monotherapy yatanzwe nk'imiti ya mbere ya chimiotherapie guhera mu Ukuboza 2019. Mu gihe cyo kubaga imirasire yo kugabanya ububabare mu gace k'ubutabazi, hagaragaye ko ikibyimba cyagaragaye mu bihaha. Kubera ko CLDN18.2 yagaragaye ko ari 3+/60%, umurwayi yinjiye mu igerageza rya CT041. Nyuma yo guhabwa lymphodepletion igizwe na fludarabine, cyclophosphamide na nab-paclitaxel, umurwayi yatewe dose ya CT041 ya 250 × 10.⁶Uturemangingo muri Nyakanga 2021. Umurwayi yagize CRS yo mu rwego rwa 2, yongera gupimwa na tocilizumab. PR yagezweho kuva aho isuzuma rya mbere ryakorewe nyuma y'ibyumweru 4 nyuma yo guterwa. Ibisebe byatewe n'ibihaha byagiye bishira maze bikira burundu. Ikibyimba cyari kigicungwa kugeza igihe gikurikiranwe bwa nyuma muri Nyakanga 2023. Umubare wa kopi y'amaraso yo mu gice cya CLDN18.2 CAR mu barwayi bombi wagaragaje ukwiyongera vuba nyuma yo guterwa, bizamuka mu byumweru 2. Muri icyo gihe, ibisubizo byo gutondeka uturemangingo twakoreshejwe n'urumuri byagaragaje ukwiyongera kwa CD8 T mu maraso yo mu gice cya Treg, hamwe no kugabanuka kwa CD4 T na B. Izi mpinduka mu miterere y'uturemangingo tw'ubudahangarwa bw'umubiri zagaragaje ko tudashobora kwihanganira cyane ugereranije n'impinduka mu rugero rwa cytokine.

Kuri ubu, hari andi magerageza menshi ya CAR-T mu Bushinwa, kandi barimo gushaka abarwayi. Kugira ngo ubone inama ku miti mishya n'ikoranabuhanga, ushobora kuvugana n'Ishami Mpuzamahanga ry'Ibitaro bya Oncology bya Beijing Region South.

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Amareferensi

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