satricabtagene autoleucel（Satri-cel,CT041)

Ko te satricabtagene autoleucel（Satri-cel,CT041) he hua pūtau-T CAR autologous e taea ai te whawhai ki te pūmua Claudin18.2, ā, tera pea ka noho ko ia te tuatahi o te ao. E aro ana a Satri-cel ki ngā pukupuku totoka Claudin18.2 pai, me te arotahi matua ki te mate pukupuku puku/mate pukupuku hononga gastroesophageal (GC/GEJ) me te mate pukupuku repeure (PC).

Kua whakaputaina ngā hua whakamutunga o te whakamātautau i tīmatahia e te kairangahau, arā, te CT041-CG4006 (NCT03874897) o te satricabtagene autoleucel, ki roto i te Nature Medicine i te 3 o Hune, 2024.

E 98 ngā tūroro i uru ki te whakamātautau, ā, i whakaatuhia e ngā hua ko te tere whakahaere mate (DCR) he teitei ki te 91.8%, e 38 ngā tūroro i tutuki i te murunga mate, ko te tere murunga mate whānui he 38.8%, ko te roanga oranga kore whanaketanga (PFS) he 4.4 marama, ko te roanga oranga whānui (OS) he 8.8 marama, ā, ko te roanga oranga waenga (mDOR) he 6.4 marama. I roto i ngā tūroro whara whāinga turanga e 90, e 70 ngā tūroro i tutuki i ngā taumata rerekē o te whakahekenga o te pukupuku.

I roto i te 51 o ngā tūroro mate pukupuku puku i rongoatia ki te Satri-cel kotahi, ko te reiti whakahaere mate i eke ki te 96.1% (49), ā, ko te reiti urupare whānui ko te 54.9% (28). I roto i a rātou, 27 ngā tūroro i eke ki te urupare hapa (PR), 1 te tūroro i eke ki te urupare katoa (CR), ā, ko te roanga waenga o te urupare (mDOR) he 6.4 marama.

Whakamutunga

E whakaatu ana a Satri-cel i te kaha rongoā me te kōtaha haumaru e taea te whakahaere i roto i ngā tūroro e pangia ana e te mate pukupuku puku matatau CLDN18.2-pai.

I te 9 o Hepetema, 2023, e rua ngā kēhi o te maimoatanga o te mate pukupuku repe taikaha kua horapa ki te CARsgen's CT041, he rongoā auaha a Claudin (CLDN) 18.2 CAR T-cell Therapy, i whakaputaina ki te Journal of Hematology & Oncology ko "CT041 CAR T cell therapy for Claudin18.2 positive metastatic pancreatic cancer".

Mō te take 1, i kitea he mate pukupuku repeure i roto i tētahi wahine 58-tau te pakeke, ā, kua horapa ki roto i ngā pūkahukahu me ngā kōpū lymph. Kāore i angitu te whakamahi i te nab-paclitaxel raina tuatahi me te gemcitabine me te irinotecan-liposome raina tuarua me te 5-flurouracil i mua i tana whakaurunga ki te whakamātautau haumanu CT041, whai muri i te whakaū i te whakaaturanga CLDN18.2 hei 2+/70%. Whai muri i te lymphodepletion i titoa mai i te fludarabine, cyclophosphamide, me te nab-paclitaxel, he horopeta CT041 o te 250 × 10⁶I tukuna ngā pūtau ki te tūroro i te marama o Hepetema 2021. I puta te mate tukunga cytokine (CRS) taumata 2, ā, i muri mai ka whakahaerea e te tocilizumab. I tutuki te urupare wāhanga (PR) e ai ki te RECIST v1.1, me te whakahekenga nui o te metastasis o te pukahukahu.

Mō te take 2, i kitea he mate pukupuku repeure pT2N0 tō tētahi wahine 75-tau te pakeke i muri i tana pokanga i te marama o Mei 2019. I kitea te horapa o te mate pukupuku ki roto i te pūkahukahu i muri i te 5 marama i te wā o te whai muri i te pokanga. I tukuna te rongoā S-1 hei rongoā tuatahi mai i Hakihea 2019. I te wā o te irahiko whakaora i te wāhi pokanga, i kitea te whanaketanga o te pukupuku i roto i te pūkahukahu. Mai i te mea i whakatauhia te whakaaturanga CLDN18.2 he 3+/60%, i whakaurua te tūroro ki te whakamātautau haumanu CT041. Whai muri i te whiwhinga o te lymphodepletion kei roto ko te fludarabine, cyclophosphamide me te nab-paclitaxel, i werohia te tūroro ki te horopeta CT041 o te 250 × 10.⁶ngā pūtau i te Hōngongoi 2021. I pāngia te tūroro e te CRS taumata 2, i whakahaeretia anō ki te tocilizumab. I tae atu te PR mai i te aromatawai tuatahi 4 wiki i muri i te werohanga. I ngaro ngā whara ūnga o te metastasis pukahukahu i muri mai, ā, i tutuki te urupare katoa. I raro tonu i te mana whakahaere pai te pukupuku tae noa ki te whai muri whakamutunga i te Hōngongoi 2023. Ko te maha o ngā tārua CAR toto ā-taha CLDN18.2 i roto i ngā tūroro e rua i whakaatu i te pikinga tere i muri i te werohanga, ā, i eke ki tōna taumata i roto i ngā wiki e 2. I te wā kotahi, ko ngā hua o te whakarōpū pūtau whakahohe-fluorescence i tohu i te pikinga o ngā pūtau CD8 T toto ā-taha me ngā pūtau Treg, me te whakahekenga o ngā pūtau CD4 T me ngā pūtau B. Ko ēnei nekehanga i roto i ngā momo pūtau ārai mate i whakaatu i te pumau nui ake i ngā huringa o ngā taumata cytokine.

I tēnei wā, he maha atu ngā whakamātautau haumanu CAR-T i Haina, ā, kei te rapu tūroro rātou. Mō te kōrerorero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.

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Ngā Tohutoro

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