Na Julaị 20, a ga-eme emume iji ọgwụ ọhụrụ ahụ.(NDA) nke pCAR-19B nke Precision Biology mepụtara n'onwe ya ka China National Medical Products Administration (NMPA) nabatara n'ihu ọha. Ngwaahịa a bụ ngwaahịa CAR-T mbụ maka leukemia ụmụaka na China, nke a na-eji agwọ ndị ọrịa dị afọ 3-21 nwere ọrịa leukemia lymphoblastic acute CD19-positive relapsed/refractory (ALL).
Ọrịa leukemia lymphoblastic dị oke njọ (ALL) bụ otu n'ime ọrịa kansa kachasị njọ n'ime ụmụaka ma bụrụkwa ihe kacha akpata ọnwụ n'ime ụmụaka na ndị ntorobịa. Ọgwụgwọ mkpụrụ ndụ chimeric antigen receptor (CAR-T) agbanweela ọgwụgwọ nke relapsed/refractory (R/R) B-cell ALL, site na ngwaahịa mbụ FDA kwadoro, Kymriah (tisagenlecleucel) nke Novartis mepụtara, na-eme ka ọnụego mgbaghara na oge ndụ dịkwuo mma nke ukwuu.
pCAR-19B bụ ngwaahịa mkpụrụ ndụ CAR-T nke nwere akụkụ mgbanwe CD19 nke a haziri nke ọma (scFv) nke e mere iji dozie nsogbu nchekwa.
Na Nọvemba 2023, gọọmentị China National Medical Products Administration enyela pCAR-19B "Nhọpụta Ọgwụgwọ Na-aga nke Ọma" maka ọgwụgwọ B-ALL.
Nsonaazụ arụmọrụ na nchekwa nke pCAR-19B n'ime nnwale ahụike dị mkpa nke metụtara ụmụaka na ndị okenye China nwere R/R B-cell niileekwuputara naNzukọ Kwa Afọ nke 66 nke American Society of Hematology (ASH).
Usoro: Nnwale nkebi nke abụọ a (NCT05334823) bụ ọmụmụ otu aka, nke mepere emepe, nke nwere ọtụtụ ebe. Ndị ọrịa dị afọ ≥ 3 na ≤ afọ 21 mgbe a na-enyocha ha na CD19+ R/R B-ALL akwadoro ka agụnyere. Isi ihe dị mkpa bụ ọnụego mgbaghara zuru oke (ORR), nke a kọwara dị ka mgbaghara zuru oke (CR) tinyere CR yana mgbake ọbara na-ezughị ezu (CRi) n'ime ọnwa atọ mgbe a mịnyechara ya.
Nsonaazụ: Ruo Eprel 18, 2024, e debara aha ndị ọrịa 89 ma mee leukapheresis, ebe ndị ọrịa 64 natara ọgwụ pCAR-19B. Enweghị ikpe nke mmepụpụta ihe na-adịghị mma. N'ime ndị ọrịa a gbara ọgwụ, 6.25% (4/64) bụ ndị na-anaghị anabata ọgwụgwọ mbụ ma 93.75% (60/64) alaghachila n'ọtụtụ usoro ọgwụgwọ mbụ ma ọ bụ mgbanwe mkpụrụ ndụ allogeneic. Afọ etiti bụ afọ 11 (oge 3-21), na 56.25% (36/64) bụ ụmụ nwoke. Na mgbakwunye, 75% (48/64) nke ndị ọrịa ahụ bu ma ọ dịkarịa ala otu mkpụrụ ndụ ihe nketa dị oke egwu. Ibu ọkpọ ọkpụkpụ etiti (BM) na mmalite bụ 58.3% (oge 5%-98%) yana ibu BM dị arọ (≥50%) hụrụ na 56.25% nke ndị ọrịa ahụ.
N'oge nyocha nke ụbọchị 211 (n'etiti 35-750), ORR kacha mma bụ 90.63% (58/64), yana 78.13% nke ndị ọrịa (50/64) na-enweta CR na 12.5% nke ndị ọrịa (8/64) na-enweta CRi, karịa irè nke ngwaahịa ọgwụgwọ CAR-T anti-CD19 nke azụmaahịa akọpụtara na R/R B-ALL. 98.27% (57/58) nke ndị ọrịa nwere ORR nwetara mbelata ọrịa fọdụrụ (MRD) na-adịghị mma. ORR na ọnwa 3 bụ 76.56% (49/64). Oge etiti nke nzaghachi (DOR) bụ ọnwa 10.61 (nkeji ntụkwasị obi 95% 7.66-20.96). N'etiti ogologo ndụ (OS) bụ ọnwa 23.92 (nkeji ntụkwasị obi 95% 9.86-NR).
Ọrịa Cytokine release syndrome (CRS) na ọrịa neurotoxicity nke metụtara mkpụrụ ndụ ihe nketa (ICANS) mere na 98.44% na 50% nke ndị ọrịa, n'otu n'otu. A hụrụ ọkwa ≥3 CRS na ICANS na 29.69% na 39.06% nke ndị ọrịa, n'otu n'otu. Ogologo oge nke ọkwa ≥3 CRS na ICANS bụ ụbọchị 4 na ụbọchị 3, n'otu n'otu. Enweghị ọnwụ ọ bụla sitere na CRS ma ọ bụ ICANS.
Mmechi: N'agbanyeghị nnukwu ibu nke mgbawa BM na nnukwu ihe egwu nke mgbanwe mkpụrụ ndụ ihe nketa, pCAR-19B gosipụtara oke mbelata dị elu, nweta oke mbelata MRD-negative, nzaghachi na-adịgide adịgide, na profaịlụ nchekwa a na-anabata. Ọmụmụ ihe a na-anọchite anya nnwale ahụike mbụ dị mkpa nke B-ALL nwata na ndị Eshia, na-enye nhọrọ ọgwụgwọ ọhụrụ maka ụmụaka China na ndị okenye toro eto nwere R/R B-ALL.
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
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Ntụaka
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.http://cq.news.cn/20240728/b0a74788930d4be7a45996be2808dd4f/c.html
4.https://ash.confex.com/ash/2024/webprogram/Paper206408.html
5.https://ashpublications.org/blood/article/140/Supplement%201/4625/491174/The-Safety-and-Efficacy-of-p-CAR-19B-a-Scfv
Oge ozi: Nọvemba-22-2024