satricabtagene autoleucel (Satri-cel, CT041)

satricabtagene autoleucel（Satri-cel,CT041) bụ ọgwụ CAR T-cell nke nwere ike ịlụso protein Claudin18.2 ọgụ nke nwere ike ịbụ nke mbụ n'ụwa niile. Satri-cel na-elekwasị anya na etuto siri ike nke Claudin18.2, nke bụ isi ihe na-elekwasị anya na kansa afọ/ọrịa gastroesophageal junction cancer (GC/GEJ) na kansa pancreatic (PC).

E bipụtala nsonaazụ ikpeazụ nke nnwale CT041-CG4006 (NCT03874897) nke satricaabtagene autoleucel nke onye nyocha malitere na Nature Medicine na June 3, 2024.

Ngụkọta ndị ọrịa 98 sonyere na nnwale ahụ, ihe si na ya pụta gosiri na ọnụego njikwa ọrịa (DCR) dị elu ruo 91.8%, ndị ọrịa 38 nwetara mgbaghara, ọnụego mgbaghara zuru oke bụ 38.8%, ndụ ndụ na-enweghị ọganihu (PFS) bụ ọnwa 4.4, ndụ ndụ zuru oke (OS) bụ ọnwa 8.8, oge ọgwụgwọ (mDOR) bụ ọnwa 6.4. N'ime ndị ọrịa 90 e lekwasịrị anya na mmerụ ahụ, ndị ọrịa 70 nwetara ọkwa dị iche iche nke mbelata etuto ahụ.

N'ime ndị ọrịa kansa afọ iri ise na otu ejiri Satri-cel gwọọ otu ọgwụgwọ, ọnụego njikwa ọrịa ahụ ruru 96.1% (49), ọnụego nzaghachi zuru oke bụ 54.9% (28). N'ime ha, ndị ọrịa iri abụọ na asaa nwetara nzaghachi akụkụ (PR), otu onye ọrịa nwetara nzaghachi zuru oke (CR), oge nzaghachi etiti (mDOR) bụ ọnwa 6.4.

Mmechi

Satri-cel na-egosi ike ọgwụgwọ yana profaịlụ nchekwa a na-achịkwa nke ọma na ndị ọrịa nwere ọrịa kansa eriri afọ nke CLDN18.2-positive.

Na Septemba 9, 2023, e bipụtara ikpe abụọ nke ọgwụgwọ kansa pancreatic metastatic site na iji CARsgen's CT041, Claudin (CLDN) 18.2 CAR T-cell Therapy, na Journal of Hematology & Oncology nke akpọrọ "CT041 CAR T cell therapy for Claudin18.2 positive pancreatic cancer" .

Maka ikpe nke mbụ, a chọpụtara na otu nwanyị dị afọ iri ise na asatọ nwere kansa pancreas nwere metastasis nke ngụgụ na lymph nodes. E nweghịzi ike iji nab-paclitaxel nke mbụ gbakwunyere gemcitabine na nke abụọ irinotecan-liposome gbakwunyere 5-flurouracil tupu e debanye aha ya na nnwale ahụike CT041, mgbe o kwusịrị na ngosipụta CLDN18.2 dị ka 2+/70%. Mgbe lymphodepletion nke gụnyere fludarabine, cyclophosphamide, na nab-paclitaxel gasịrị, a na-enye ya ọgwụ CT041 nke 250 × 10.⁶E nyere onye ọrịa ahụ mkpụrụ ndụ na Septemba 2021. Ọrịa mwepụ cytokine nke ọkwa nke abụọ (CRS) mere, nke tocilizumab mechara chịkwaa. E nwetara nzaghachi akụkụ (PR) dịka RECIST v1.1 si kwuo, yana nnukwu mbelata nke metastasis nke akpa ume.

Maka ikpe nke abụọ, a chọpụtara na otu nwanyị dị afọ 75 nwere kansa pancreatic pT2N0 mgbe a wachara ya ahụ na Mee 2019. A chọpụtara na ọ na-akpata ọrịa akpa ume mgbe ọnwa ise gachara n'oge a na-eme nyocha mgbe a wachara ya ahụ. E nyere S-1 monotherapy dị ka chemotherapy mbụ site na Disemba 2019. N'oge a na-awa ahụ, a hụrụ ọganihu etuto ahụ n'akpa ume. Ebe ọ bụ na achọpụtara na CLDN18.2 bụ 3+/60%, e debanyere aha onye ọrịa ahụ na nnwale ahụike CT041. Mgbe ọ natara lymphodepletion nke gụnyere fludarabine, cyclophosphamide na nab-paclitaxel, a mịnyere onye ọrịa ahụ dose CT041 nke 250 × 10⁶mkpụrụ ndụ na Julaị 2021. Onye ọrịa ahụ nwetara CRS ọkwa nke abụọ, nke ejiri tocilizumab chịkwaa. E mechara nweta PR kemgbe nyocha mbụ ahụ izu anọ ka etinyere ya. Mmerụ ahụ nke metastasis akpa ume kwụsịrị wee nweta nzaghachi zuru oke. A ka nọ n'okpuru njikwa nke ọma ruo mgbe e mechara nyocha ikpeazụ na Julaị 2023. Nọmba nchịkọta ọbara CLDN18.2 CAR n'ime ndị ọrịa abụọ ahụ gosipụtara mmụba ngwa ngwa mgbe etinyere ya, nke ruru n'ime izu abụọ. N'otu oge ahụ, nsonaazụ nhazi mkpụrụ ndụ nke fluorescence mere ka ọ pụta ìhè na mmụba na mkpụrụ ndụ CD8 T na mkpụrụ ndụ Treg n'ọbara, yana mbelata na mkpụrụ ndụ CD4 T na mkpụrụ ndụ B. Mgbanwe ndị a na ụdị mkpụrụ ndụ ahụ ji alụso ọrịa ọgụ gosipụtara ntachi obi ka ukwuu ma e jiri ya tụnyere mgbanwe na ọkwa cytokine.

Ugbu a, enwere ọtụtụ nnwale ụlọ ọgwụ CAR-T ndị ọzọ na China, ha na-achọkwa ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ ọhụrụ na teknụzụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.

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Ntụaka

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