ʻIkepili Lapaʻau Hou Loa o RD13-02 no ka mālama ʻana i nā maʻi R/R T-ALL/LBL ma ka hōʻike waha

He huahana kelepona CAR-T honua ʻo RD13-02 e kuhikuhi ana iā CD7 i loaʻa mai nā mea hāʻawi olakino, a ua manaʻo ʻia no ka mālama ʻana i ka leukemia/lymphoma lymphoblastic acute T-cell (T-ALL/LBL) i hoʻihoʻi ʻia a paʻakikī paha. Ua hoʻololi ʻia ke ʻano genetic e pale aku i ka fratricide, ka maʻi graft-versus-host (GvHD), a me ka hōʻole ʻana o ka host-versus-graft (HvG) me ka hoʻoikaika ʻana i ka hana anti-tumor. Hiki ke hoʻomākaukau ʻia ʻo RD13-02 i hoʻokahi pūʻulu no nā poʻe he nui, e hoʻokō ana i kahi hiki "off-the-shelf" no nā poʻe maʻi e pono ai ka lāʻau lapaʻau kelepona CAR-T.

Ma Nowemapa 7, 2024, ua hoʻolaha ʻo Bioheng Therapeutics e hōʻike ana i ka ʻikepili lapaʻau Phase I hou loa o kāna huahana CAR-T cell RD13-02, e kuhikuhi ana iā CD7 no ka mālama ʻana i nā maʻi T-ALL/LBL relapsed/refractory(R/R), ma kahi hōʻike waha ma ka 66th American Society of Hematology (ASH) Annual Meeting. E mālama ʻia ka ʻaha kūkā mai Dekemaba 7-10, 2024, ma San Diego, USA.

Nā Hualoaʻa: Ma ka lā 1 o ʻAukake, 2024, ua kākau inoa ʻia he 18 mau pts kūpono me R/R T-ALL/LBL (13 ALL, 5 LBL), me ka makahiki waena o 33.5 mau makahiki (mai ka pae, 11 a 67). ʻO ka awelika o nā laina lapaʻau mua he 2 (mai ka pae, 1 a 5), ​​a he 4 mau pts i loaʻa mua i ka allo-HSCT ma mua o ke kākau inoa ʻana. ʻO ka hapa waena o nā pahū BM he 71% (mai ka pae: 6% a 90%) ma waena o 18 pts, me 9 (6 ALL, 3 LBL) e hōʻike ana i ka hoʻopili ʻana ma waho o ka medullary. ʻAʻohe hanana toxicity palena dose (DLT) a i ʻole neurotoxicity i ʻike ʻia ma nā pae dose āpau, me hoʻokahi wale nō hihia o Gr1 GvHD e hana nei. Ua hiki ke hoʻokele ʻia ka maʻi hoʻokuʻu Cytokine (CRS) me ka hapa nui he akahai (Gr1, n=10; Gr2, n=5; Gr3, n=3). Ua loaʻa nā maʻi āpau-papa i 13 (72%) pts (≥Gr3 i 2 [11%] pts). Ma muli o ka loaʻa ʻana o Gr3 CRS i hoʻokahi pt mai nā pae DL2 a me DL3, ua hoʻonohonoho nā mea noiʻi i ka DL1 ma ke ʻano he mahele hoʻonui me ka nānā nui ʻana i ka palekana a me ka pono. I ka wā o ka hoʻonui ʻana o ka mahele, ua make kekahi pt mai ka tumor lysis syndrome ma ka lā 20 ma hope o ka hoʻokomo ʻana.

I ka loiloi mua ʻana he 28 lā ma hope o ka hoʻokomo ʻana, ua loaʻa i 14 o 17 mau pts loiloi ʻia ka CR/CRi. ʻOiai ma ka mahina ʻelua ma hope o ka hoʻokomo ʻana, ua hōʻea ʻelua mau pts hou i ka CR/CRi, me ka helu CR/CRi o 94% (16/17). Ma waena o nā pts me CR/CRi, ua loaʻa i ka 100% ka liʻiliʻi o ke kūlana maʻi koena (MRD) maikaʻi ʻole ma o ka nānā ʻana i ka cytometry kahe. ʻO ka median Cmax o nā cell CAR-T i loko o ke koko peripheral he 1,863,601 kope/μg genomic DNA (range, 275,044 a 3,763,587) e qPCR, me ka lōʻihi loa o ka lōʻihi ma mua o 90 mau lā.

Hopena: Ua hōʻike ʻo RD13-02, kahi huahana CAR-T ākea "off-the-shelf", i kahi ʻano palekana hiki ke hoʻokele ʻia a me ka pono i hoʻonui ʻia i ka mālama ʻana iā R/R CD7 T-ALL/LBL. ʻO ka mea nui, ua loaʻa i ka 100% o nā pts CR/CRi ke kūlana MRD-maikaʻi ʻole, e hāʻawi ana i nā pts i nā koho lapaʻau wikiwiki hou aku.

I kēia manawa, nui nā hoʻokolohua lapaʻau CAR-T ʻē aʻe ma Kina, a ke ʻimi nei lākou i nā maʻi. No ke kūkākūkā ʻana i nā lāʻau lapaʻau hou a me nā ʻenehana, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.

Helu Kelepona：4008803716

Email：myimmnet@163.com

Nā Kuhikuhi

1.https://www.bioheng.com/News_Details/26.html

2.https://ash.confex.com/ash/2024/webprogram/Paper207322.html

3.http://myimm.net/mianyizhiliao/2035.html