Equecabtagene autoleucel (eque-cel)

Equecabtagene autoleucel (eque-cel), oo ah daaweyn T-cell ah oo si buuxda uga soo jeeda bini'aadamka oo loo yaqaan 'B-cell maturing antigen-bartilmaameedsan chimeric antigen receptor (CAR), ayaa muujisay awood ay ku daweyn karto cudurka 'multiple myeloma' ee soo noqnoqda ama aan la qabsan karin (R/RMM).

Juun 30, 2023, Maamulka Badeecadaha Caafimaadka Qaranka ee Shiinaha (NMPA) ayaa ansixiyay Codsiga Daawada Cusub (NDA) ee FUCASO (Equecabtagene Autoleucel) oo ah daaweynta unugyada T-cell ee ugu horreysay adduunka ee antigen-ka unugyada B ee bislaaday (BCMA) ee chimeric antigen receptor (CAR) ee loogu talagalay daaweynta R/RMM kuwaas oo helay ≥3 xariiq oo daaweyn hore ah oo ay ku jiraan ugu yaraan hal ka hortage proteasome iyo wakiil immunomodulatory ah.

Noofambar 7, 2024, IASO Biotherapeutics waxay ku dhawaaqday in natiijooyinka daraasadda kiliinikada ee wejiga 1b/2 ee FUMANBA-1 ee daaweynta gebi ahaanba aadanaha ee ka hortagga BCMA CAR-T, Equecabtagene Autoleucel (magaca ganacsiga: Fucaso™), ee loogu talagalay daaweynta R/RMM, lagu daabacay joornaalka caafimaadka ee ugu horreeya JAMA Oncology. Daraasaddu waxay qiimaysay waxtarka iyo badbaadada Equecabtagene Autoleucel ee bukaanada qaba R/RMM kuwaas oo hore u helay ≥3 xariiq oo daaweyn hore ah. Natiijooyinka waxay muujiyeen in Equecabtagene Autoleucel ay gaartay heer jawaab celin guud oo sare iyo cafis waara oo bukaanada ah, iyadoo leh muuqaal badbaado oo wanaagsan.

FUMANBA-1 waa daraasad caafimaad oo diiwaan-gelin ah oo hal-gacan ah oo leh calaamad furan oo wejiga 1b/2 ah oo lagu sameeyay 14 xarumood oo Shiinees ah si loo qiimeeyo waxtarka iyo badbaadada Equecabtagene Autoleucel ee bukaanada qaba R/RMM kuwaas oo helay ≥3 xariiqood oo daaweyn hore ah. Tijaabadu waxay diiwaangelisay bukaanada qaba R/RMM kuwaas oo hore u helay ugu yaraan saddex xariiq oo daaweyn ah, oo ay ku jiraan daawooyinka ka hortagga proteasome iyo daawooyinka kiimoterabiga ee ku salaysan wakiilada difaaca jirka, waxayna lahaayeen horumar cudur oo ku yimid daaweyntoodii ugu dambeysay. Bukaannada hore u helay daaweynta BCMA CAR-T ayaa sidoo kale xaq u lahaa inay isdiiwaangeliyaan.

Natiijooyinka103 bukaan oo la siiyay daawadii eque-cell, 55 (53.4%) waxay ahaayeen rag, da'da dhexdhexaadka ahna waxay ahayd 58 (39-70) sano. Marka la eego dabagalka dhexdhexaadka ah (kala duwanaanshaha) ee 13.8 (0.4-27.2) bilood, Marka la eego waxtarka, 101 bukaan oo la qiimeyn karo, heerka guud ee jawaabta (ORR) wuxuu ahaa 96.0% (97/101), heerka jawaabta dhammaystiran/dhammaystirka ee adag (sCR/CR) wuxuu ahaa 74.3% (75/101). 89 bukaan oo aan lahayn daawayn CAR-T hore, ORR wuxuu ahaa 98.9% (88/89), heerka sCR/CR wuxuu ahaa 78.7% (70/89). 101-kan bukaan, waqtiga dhexdhexaadka ah ee jawaab celinta wuxuu ahaa 16 maalmood (inta u dhaxaysa: 11-179), halka muddada dhexdhexaadka ah ee jawaab celinta (DOR) iyo badbaadada aan horumarka lahayn (PFS) aan weli la gaarin. Heerka PFS ee 12-ka bilood ah wuxuu ahaa 78.8% (95% CI: 68.6-86.0). Intaa waxaa dheer, 95% (96/101) bukaannada waxay gaareen taban ugu yar ee cudurka haray (MRD), iyadoo waqti dhexdhexaad ah ilaa taban MRD uu yahay 15 maalmood (inta u dhaxaysa: 14-186). Dhammaan bukaannada qaba sCR/CR waxay gaareen taban MRD, muddada dhexdhexaadka ah ee taban MRD lama gaarin.

Gunaanad iyo MuhiimaddaTijaabadan, eque-cel waxay keentay jawaabo hore, qoto dheer, iyo waara bukaanada qaba R/RMM-ka aadka loo daaweeyay oo leh astaamo badbaado oo la maarayn karo. Bukaannada hore ee daaweynta CAR T-cell ayaa sidoo kale ka faa'iidaystay eque-cel.

Waqtigan xaadirka ah, waxaa jira tijaabooyin caafimaad oo badan oo CAR-T ah oo ka jira Shiinaha, waxayna raadinayaan bukaanno. Si aad ula tashato daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.

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Tixraacyada

1.https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20230630195006116.html

2.https://en.iasobio.com/info.php?id=224

3.http://js.news.cn/20230926/c8e67444df624a5ea654dda3aa608689/c.html

4.https://en.iasobio.com/info.php?id=256

5.https://jamanetwork.com/journals/jamaoncology/article-abstract/2826068