Na ụbọchị asaa nke ọnwa Ọgọstụ, Center for Drug Evaluation (CDE) nke National Medical Products Administration (NMPA) kwupụtara na atụọla aro ka a tinye ọgwụ PA3-17 n'ọkwa ọgwụgwọ ọhụrụ, nke e mere maka ọgwụgwọ ndị okenye nwere ọrịa T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL) nke na-alaghachi azụ/na-adịghị ike.
Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.
Nọmba ekwentị: 4008803716
WeChat ID: 17801183037
Ozi ịntanetị:myimmnet@163.com
Ndị ọrịa nwere ọrịa leukemia/lymphoma T-lymphoblastic nke na-alọghachi azụ/na-anaghị anabata ọgwụgwọ (r/r T-ALL/LBL) na-apụta ìhè n'ọrịa site na ọganihu ngwa ngwa nke ọrịa, enweghị amụma na enweghị nhọrọ ọgwụgwọ. Ugbu a, naanị Nailabine ka FDA kwadoro na 2005 maka ọgwụgwọ nke ndị ọrịa T-ALL/LBL bụ ndị na-anaghị anabata ma ọ dịkarịa ala usoro ọgwụgwọ chemotherapy abụọ ma ọ bụ ndị na-alaghachi azụ mgbe ọgwụgwọ gasịrị, yana ORR nke 31% na CR nke 23%. Ya mere, enwere mkpa dị ngwa iji mepụta usoro ndị ọzọ dị irè. E wezụga ngosipụta ya na mkpụrụ ndụ T na NK nkịtị na enweghị ngosipụta na mkpụrụ ndụ anụ ahụ ndị ọzọ, a na-egosipụta CD7 nke ọma na mkpụrụ ndụ T-ALL/LBL. Ya mere, a na-ewere CD7 dị ka ihe mgbaru ọsọ nwere ike ime maka mmepe nke ọgwụgwọ CAR-T maka T-ALL/LBL. Otú ọ dị, ihe ịma aka bụ izere fratricide nke ngosipụta nke CD7 na mkpụrụ ndụ T kpatara. Ndị nchọpụta mepụtara ọgwụ CAR-T nke dabere na ọgwụ mgbochi CD7 nano, nke a na-akpọ PA3-17 injection, site na igbochi ngosipụta nke molekul CD7 n'elu mkpụrụ ndụ T site na ihe mgbochi ngosipụta protein anti-CD7 (PEBL).
E gosipụtara data nleba anya ogologo oge sitere na nnwale ahụike nke Phase I nke ọgwụ PA3-17 maka ọgwụgwọ nke ọrịa leukemia/lymphoma lymphoblastic acute T-cell nke na-alaghachi azụ/na-adịghị ike (R/R T-ALL/LBL) na ogbako agụmakwụkwọ nke mba ụwa nke a kwadoro na EHA 2025.
Ruo Febụwarị 19, 2025, e debara aha ndị ọrịa 13 (ndị ọrịa 3 n'ime dose nke 1, otu 2, otu 3, ndị ọrịa 4 n'ime otu RP2D), ha niile natara otu ọgwụ PA3-17 ma mechaa nyocha nke ụbọchị 28 nke na-ebelata nsí (DLTs). E guzobere RP2D na 2×10⁶ CAR-T/kg dabere na pharmacokinetics, nchekwa na arụmọrụ karịa dose a. Enweghị DLT mere na erughi oke dose a kwadoro (MTD). Ọnọdụ Cytokine release syndrome (CRS) bụ 84.6% (G3:23.1%, enweghị G4), ebe ọrịa neurotoxicity metụtara sel immunoeffector (ICANS) bụ naanị na G1-2 (15.4%). Data arụmọrụ gosiri na ọnụego nzaghachi kacha mma (ORR) bụ 84.6% (11/13) na 76.9% (10/13) nwetara mgbaghara zuru oke/mweghachi zuru oke site na mgbake ọnụọgụgụ zuru oke (CR/CRi). Ihe dị ịtụnanya bụ na 69.2% (9/13, ndị ọrịa CR 8) nọgidere na-azaghachi n'ime ọnwa 3, yana 50.0% (4/8) na-ejigide CR ＞ọnwa 15 mgbe a mịnyechara ya na-enweghị mgbanwe mkpụrụ ndụ stem (SCT) sochirinụ, abụọ n'ime ha ka nwere mkpụrụ ndụ CAR-T a na-achọpụta na ọnwa 21. Ihe pụrụ iche bụ na onye ọrịa a gwọrọ nke ukwuu [ọrịa Hematopoietic Stem Cell Transplantation (HSCT) tupu ya, ọrịa buru ibu ＞7cm] ruru CR site na ụbọchị 28 na HSCT nke abụọ na ọnwa 6.
Ọgwụ PA3-17 gosiri na ọ dị mma ịnagide ọrịa ahụ, ọ na-arụ ọrụ dị omimi ma na-adịgide adịgide n'ime ndị ọrịa T-ALL/LBL r/r nke ukwuu, ebe pasentị iri ise nke ndị ọrịa CR ka dị ndụ ma ọ bụ na-enweghị ọganihu mgbe otu afọ gasịrị.
Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.
Nọmba ekwentị: 4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
Oge ozi: Ọgọst-13-2025