Kua whakaaetia a Zevor-cel kia whakarārangihia

I te 1 o Poutū-te-rangi, 2024, i whakaaetia e te Whakahaere Hua Hauora ā-Motu o Haina (NMPA) te whakarewatanga o te hua pūtau CAR-T Zevorcabtagene AutoLeucel (Zevor-cel, CT053) hei rongoā i ngā tūroro pakeke e pāngia ana e te myeloma maha kua hoki mai anō, kua uaua rānei te whakatika i te mate, ā, kua whanake haere i muri i te toru o ngā momo rongoā (mā te whakamahi i te kotahi te aukati proteasome me te kaiwhakatikatika ārai mate).

Ko te nuinga o tēnei rārangi e ahu mai ana i tētahi whakamātautau haumanu wāhanga II tuwhera-tapahanga, kotahi-ringa, maha-pokapū (LUMMICAR STUDY 1,NCT03975907) i Haina, i tutuki ai te reiti murunga 100%.

14 ngā tūroro, ko te pakeke toharite o te 54 tau (awhe：34-62), i whiwhi i te werohanga kotahi o te zevor-cel. I te 17 o Hūrae, 2023, ko te roanga toharite o te aroturukitanga he 37.7 marama (awhe:14.8-44.2 marama). Ko te reiti urupare whānui (ORR) he 100% (14/14) me te 78.6% (11/14) ngā tūroro i eke ki te urupare katoa (CR) me te urupare katoa pakari (sCR); i eke ki te iti rawa o te mate toenga (MRD) i roto i ngā tūroro katoa i eke ki te CR, ki te sCR rānei. Ko te roanga toharite o te urupare (mDOR) he 24.1 marama i roto i ngā tūroro katoa, ā, 26.0 marama i roto i te hunga i eke ki te CR, ki te sCR rānei. Ko te oranga kore-haere whakamua toharite (mPFS) he 25.0 marama. E 7 (50%) ngā tūroro katoa i roto i te whakaoranga roa atu i te 24 marama. Kāore i eke ki te toharite o te oranga whānui (OS), ā, 92.9% (13/14) o ngā tūroro i ora tonu i te marama 36.

Haumaru
I te nuinga, i taea te whakahaere i te āhua haumaru o te zevor-cel. Kāore he mate tukunga cytokine (CRS) ≥ Tau 3. Kāore he mate paitini io e pā ana ki ngā pūtau ārai mate (ICANS) o tētahi taumata. E toru ngā mate urutā Tau 3 e pā ana ki te maimoatanga i kitea. E toru ngā tūroro i pāngia e ngā mate kino nui (SAE) tae atu ki te 2 ngā tūroro i pāngia e ngā SAE e pā ana ki te maimoatanga, arā, te mate pūkahukahu me te mate pukupuku. E 2 ngā mate katoa i roto i te rangahau; kāore tētahi o ēnei i pā ki a zevor-cel.

Whakamutunga
I whakaatu a zevor-cel i tētahi kōtaha haumaru whakatenatena me ngā urupare hohonu, roa hoki, e rite ana ki ngā hua tuatahi.

I tēnei wā, he maha atu ngā whakamātautau haumanu CAR-T i Haina, ā, kei te rapu tūroro rātou. Mō te kōrero mō ngā rongoā me ngā hangarau hou, whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing: 4008803716.

Ngā Tohutoro

1.https://www.carsgen.com/cn/

2.http://sh.news.cn/20240314/2913c85a84be4fbf9345efbd48006971/c.html

3.http://myimm.net/mianyizhiliao/1413.html

4.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20240301143753188.html