satricabtagene autoleucel (Satri-cel,CT041)

satricabtagene autoleucel (Satri-cel, CT041) ke sehlahisoa sa sele ea CAR T se ikemetseng khahlanong le protheine ea Claudin18.2 e nang le monyetla oa ho ba ea pele lefatšeng ka bophara. Satri-cel e shebane le lihlahala tse tiileng tse ntle tsa Claudin18.2 ka ho shebana haholo le kankere ea mala/mofetše oa gastroesophageal junction (GC/GEJ) le kankere ea pancreatic (PC).

Liphetho tsa ho qetela tsa teko e qaliloeng ke mofuputsi CT041-CG4006 (NCT03874897) ea satricabtagene autoleucel li phatlalalitsoe ho Nature Medicine ka la 3 Phuptjane, 2024.

Palo yohle ya bakudi ba 98 e nkile karolo tekong ena, mme diphetho di bontshitse hore sekgahla sa taolo ya lefu (DCR) se ne se le hodimo ho fihla ho 91.8%, bakudi ba 38 ba fihletse phokotso, sekgahla sa phokotso ka kakaretso e ne e le 38.8%, ho phela ka nako e mahareng ntle le ho tswela pele (PFS) e ne e le dikgwedi tse 4.4, ho phela ka nako e mahareng (OS) e ne e le dikgwedi tse 8.8, mme nako e mahareng ya phokotso (mDOR) e ne e le dikgwedi tse 6.4. Har'a bakudi ba 90 ba nang le seso sa motheo, bakudi ba 70 ba fihletse maemo a fapaneng a ho fokotseha ha hlahala.

Har'a bakuli ba 51 ba kankere ea mala ba ileng ba phekoloa ka Satri-cel ka monotherapy, sekhahla sa taolo ea lefu lena se ne se le holimo ho 96.1% (49), 'me sekhahla sa karabelo ka kakaretso e ne e le 54.9% (28). Har'a bona, bakuli ba 27 ba ile ba fumana karabelo e sa fellang (PR), mokuli a le mong a fumana karabelo e felletseng (CR), 'me nako e mahareng ea karabelo (mDOR) e ne e le likhoeli tse 6.4.

Qetello

Satri-cel e bonts'a bokhoni ba kalafo ka boemo ba polokeho bo laolehang ho bakuli ba nang le kankere ea mala e tsoetseng pele ea CLDN18.2.

Ka la 9 Loetse 2023, linyeoe tse peli tsa kalafo ea kankere ea pancreatic e metastatic ka CARsgen's CT041, e leng Claudin (CLDN) 18.2 CAR T-cell Therapy e ncha, li ile tsa phatlalatsoa ho Journal of Hematology & Oncology e nang le sehlooho se reng “CT041 CAR T cell therapy for Claudin18.2 positive metastatic pancreatic cancer”.

Tabeng ea 1, mosali ea lilemo li 58 o ile a fumanoa a e-na le mofetše oa pancreatic o nang le metastasis ea matšoafo le li-lymph nodes. Nab-paclitaxel ea mola oa pele hammoho le gemcitabine le irinotecan-liposome ea mola oa bobeli hammoho le 5-flurouracil li ile tsa hloleha pele a ngolisoa tekong ea bongaka ea CT041, kamora ho netefatsa polelo ea CLDN18.2 e le 2+/70%. Kamora ho tlosoa ha lymphodepletion e nang le fludarabine, cyclophosphamide, le nab-paclitaxel, tekanyo ea CT041 ea 250 × 10⁶lisele li ile tsa fuoa mokuli ka Loetse 2021. Ho bile le lefu la ho lokolloa ha cytokine ea sehlopha sa 2 (CRS), leo hamorao le ileng la laoloa ke tocilizumab. Karabelo e sa fellang (PR) e fihletsoe ho latela RECIST v1.1, ka ho fokotseha ho hoholo ha metastasis ea matšoafo.

Tabeng ea 2, mosali ea lilemo li 75 o ile a fumanoa e le mofetše oa pancreatic oa pT2N0 ka mor'a hore a etsoe opereishene ka Mots'eanong 2019. Ho ata ha matšoafo ho ile ha fumanoa kamora likhoeli tse 5 nakong ea tlhahlobo ea kamehla ea kamora opereishene. Kalafo ea S-1 e ile ea fanoa e le chemotherapy ea mola oa pele ho tloha ka Tšitoe 2019. Nakong ea mahlaseli a palliative sebakeng sa opereishene, tsoelo-pele ea hlahala e ile ea bonoa matšoafong. Kaha polelo ea CLDN18.2 e fumanoe e le 3+/60%, mokuli o ile a ngolisoa tekong ea bongaka ea CT041. Kamora ho fumana lymphodepletion e nang le fludarabine, cyclophosphamide le nab-paclitaxel, mokuli o ile a tšeloa tekanyo ea CT041 ea 250 × 10.⁶lisele ka Phupu 2021. Mokuli o bile le CRS ea sehlopha sa 2, e ileng ea laoloa hape ka tocilizumab. PR e fihletsoe ho tloha tlhahlobong ea pele libeke tse 4 kamora ho kenngoa. Likotsi tse reriloeng tsa ho ata ha matšoafo hamorao li ile tsa nyamela 'me tsa fumana karabelo e felletseng. Hlahala e ne e ntse e laoloa hantle ho fihlela tlhahlobo ea ho qetela ka Phupu 2023. Palo ea kopi ea mali a kantle ho CLDN18.2 CAR ho bakuli ka bobeli e bontšitse keketseho e potlakileng kamora ho kenngoa, e fihlang sehlohlolong ka hare ho libeke tse 2. Ka nako e ts'oanang, liphetho tsa ho hlophisa lisele tse kentsoeng ke fluorescence li bontšitse keketseho ea lisele tsa CD8 T tsa mali a kantle ho mali le lisele tsa Treg, hammoho le phokotso ea lisele tsa CD4 T le lisele tsa B. Liphetoho tsena ho phenotype ea lisele tsa 'mele li bontšitse ho phehella ho hoholo ha ho bapisoa le liphetoho maemong a cytokine.

Hona jwale, ho na le diteko tse ding tse ngata tsa bongaka tsa CAR-T Chaena, mme di batla bakudi. Bakeng sa ditherisano mabapi le meriana le mahlale a matjha, o ka ikopanya le Lefapha la Matjhaba la Sepetlele sa Oncology sa Beijing Region South.

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Litšupiso

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