RD13-02 bụ ngwaahịa mkpụrụ ndụ CAR-T zuru ụwa ọnụ nke na-elekwasị anya na CD7 sitere na ndị na-enye onyinye ahụike, a na-emekwa ya maka ọgwụgwọ nke ọrịa leukemia/lymphoma lymphoblastic T-cell nke na-alaghachi azụ ma ọ bụ nke na-adịghị anabata. A na-agbanwe ya site na mkpụrụ ndụ ihe nketa iji zere ọrịa fratricide, ọrịa graft-versus-host (GvHD), na ịjụ host-versus-graft (HvG) ma na-eme ka ọrụ mgbochi-tumor ka mma. Enwere ike ịkwadebe RD13-02 n'otu otu maka ọtụtụ mmadụ, na-enweta ikike "anaghị adị na shelf" maka ndị ọrịa chọrọ ọgwụgwọ mkpụrụ ndụ CAR-T.
Na Nọvemba 7, 2024, Bioheng Therapeutics kwupụtara na ha ga-egosi data ahụike Phase I kachasị ọhụrụ nke ngwaahịa mkpụrụ ndụ CAR-T zuru ụwa ọnụ ya RD13-02, nke na-elekwasị anya na CD7 maka ọgwụgwọ nke ndị ọrịa T-ALL/LBL ndị na-alaghachi azụ/ndị na-adịghị ike (R/R), na ngosipụta ọnụ na Nzukọ Kwa Afọ nke 66 nke American Society of Hematology (ASH). Nzukọ a ga-eme site na Disemba 7-10, 2024, na San Diego, USA.
Nsonaazụ: Dịka ọ dị na Ọgọst 1, 2024, e debanyere aha mmadụ 18 ruru eru nwere R/R T-ALL/LBL (13 ALL, 5 LBL), ha dị afọ 33.5 (oke, 11 ruo 67). Usoro ọgwụgwọ ndị gara aga bụ 2 (oke, 1 ruo 5), ebe mmadụ 4 nwere allo-HSCT tupu e debanye aha ha. Oke nke BM blasts bụ 71% (oke: 6% ruo 90%) n'etiti mmadụ 18, ebe mmadụ 9 (6 ALL, 3 LBL) na-egosi itinye aka na mpụga medullary. Ahụghị ihe omume nsí na-egbochi dose (DLT) ma ọ bụ nsí neurotoxicity na ọkwa dose niile, naanị otu ikpe nke Gr1 GvHD na-eme. A na-achịkwa ọrịa Cytokine release syndrome (CRS) ebe ọtụtụ n'ime ha dị obere (Gr1, n=10; Gr2, n=5; Gr3, n=3). Ọrịa ọ bụla nke ọkwa ya mere na 13 (72%) pts (≥Gr3 na 2 [11%) pts). N'ihi ihe ndị mere na Gr3 CRS na otu pt nke ọ bụla site na ọkwa DL2 na DL3, ndị nyocha setịpụrụ DL1 dị ka dose mgbasawanye na-elekwasị anya na nchekwa na arụmọrụ. N'oge mgbasawanye dose ahụ, otu pt nwụrụ site na ọrịa tumor lysis syndrome n'ụbọchị 20 mgbe a mịnyechara ya.
Na nyocha mbụ nke ụbọchị iri abụọ na asatọ mgbe a mịnyechara ya, 14 n'ime 17 a na-enyocha ruru CR/CRi. Mgbe ọ ruru ọnwa nke abụọ mgbe a mịnyechara ya, 200% ndị ọzọ ruru CR/CRi, yana 94% (16/17). N'ime 200% ndị nwere CR/CRi, 100% nwetara obere ọnọdụ ọrịa fọdụrụ (MRD) site na nyocha cytometry flow. Cmax nke etiti nke mkpụrụ ndụ CAR-T dị n'ọbara dị n'akụkụ bụ 1,863,601 copies/μg genomic DNA (oke, 275,044 ruo 3,763,587) site na qPCR, yana oge kachasị ogologo gafere ụbọchị 90.
Mmechi: RD13-02, ngwaahịa CAR-T zuru ụwa ọnụ nke "anaghị arụ ọrụ nke ọma", gosipụtara profaịlụ nchekwa a na-achịkwa nke ọma ma melite arụmọrụ n'ịgwọ R/R CD7 T-ALL/LBL. Ihe pụrụ iche bụ na 100% nke CR/CRi pts nwetara ọnọdụ MRD-negative, na-enye ndị ọrịa nhọrọ ọgwụgwọ ngwa ngwa.
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.
Nọmba ekwentị: 4008803716
Email：myimmnet@163.com
Ntụaka
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
Oge ozi: Disemba-03-2024