March 2022: CAR-T kurapwa, CAR-T tekinoroji, chii CAR-T cell immunotherapy ? CAR-T mutengo wekurapa, mutengo, ichangoburwa CAR-T yekiriniki yekuedza kuunganidza ruzivo ruzivo.
The concept of boron neutron capture therapy has been proposed for decades, but it was not until last year that it really became popular among patients and became a hot spot; the antibody-drug conjugate (ADC), known as a “biomissile”, finally became popular last year. The research on CAR-T cell kurapa yakapfuurawo nemakore akawanda, asi kubvira gore rapera, kunyanya kubva pahafu yechipiri yegore rapera, nhamba huru ye CAR-T kurapwa have been “combined.”. Anti-cancer “new forces” are rapidly emerging.
Emily Whitehead, mwana wekutanga ane leukemia akarapwa CAR-T kurapa uye “mutauriri” wokurapa kweCAR-T, akakunda leukemia kweanoda kusvika makore gumi. Zvino iyi "chishamiso" kurapa kwasvika kwaari akatenderedza varwere vedu.
Kubva 2021 kusvika parizvino, kurapwa kweCAR-T kwakaratidza maitiro ekuunganidza, uye zvigadzirwa zvakawanda zvakatangwa chimwe mushure mechimwe. Munguva iyi, nyika yangu yakaunza marapiro matatu eCAR-T akatevedzana, achibvumira varwere kuona mambakwedza echirongwa chitsva.
Liso-Cel
(Lisocabtagene maraleucel, Breyanzi)
Mamiriro: Yakatenderwa kushambadzira (FDA)
Apo: Kukadzi 6, 2021
Nhanganyaya: Liso-Cel mushonga unorwisa CD19 unobva pamasero eT emurwere.
Indications: Large B-cell lymphoma (adult patients with some types of large B-cell lymphoma who have not responded to at least 2 other types of systemic therapy or have relapsed after therapy)
Inoshanda kliniki miedzo uye data:
[TRANSCEND NHL 001 muedzo (NCT02631044)] Kune varwere vanobatwa neLiso-Cel, chiyero chekuregererwa kwese chakanga chiri 73%, iyo iyo yakakwana yekuregererwa yakanga yakakwirira se53%; varwere vanogona kuwana kuregererwa kwekutanga kana kuregererwa kwechikamu mushure memwedzi we1 wekurapwa.
Pakutevera kwepakati pemwedzi ye12, 54.7% yevarwere vakaramba vari mukuregererwa kwekliniki; varwere vaiva nekufambira mberi-kusununguka kwekusununguka kwemwedzi ye6.8 uye mararamiro ehupenyu hwose hwemwedzi ye21.1; varwere vaive nezera rekupona kwegore re1%.
Axi-Cel
(Axicabtagene ciloleucel, Yescarta)
Mamiriro: Yakatenderwa kushambadzira (FDA)
Apo: Kurume 5, 2021
Introduction: The FDA has granted Yescarta, a CAR-CD19 T cell therapy, breakthrough therapy designation and priority review for the indication of follicular lymphoma. The FDA has previously approved Yescarta’s indication for large B-cell lymphoma. After this approval, Yescarta became the first CAR-T cell immunotherapy kune follicular lymphoma.
Zviratidzo: Follicular lymphoma (yakadzokazve kana kuti refractory follicular lymphoma, varwere vakuru, mushure memaitiro maviri kana kupfuura maitiro ekurapa)
Inoshanda kliniki miedzo uye data:
[ZUMA-5 muedzo] Nhamba yemhinduro yose yakasvika 91%, uye chiyero chekupindura chakakwana chakanga chakakwirira se60%; nguva yepakati yekupindura haina kusvika pakutevera kwepakati pemwedzi ye14.5, uye 74% yevarwere vane nguva yekupindura inopfuura mwedzi ye18.
Mamiriro: Yakatenderwa Kushambadzira (FDA, Supplemental Biologics License)
Chiratidzo: Yakakwirira-dose regimen yechipiri-mutsara kurapwa kwevarwere vakuru vane relapsed / refractory B-cell lymphoma.
Ide-cel
(Idecabtagene vicleucel, Abecma)
Mamiriro: Yakatenderwa kushambadzira (FDA)
Apo: Kurume 26, 2021
Nhanganyaya: Abecma ndeye BCMA-inotungamirwa autologous chimeric antigen receptor (CAR) T cell therapy yakagadzirirwa kubva kumurwere autologous T masero.
Zviratidzo: Multiple myeloma (adult patients with relapsed or refractory multiple myeloma who have received 4 or more lines of therapy, including immunomodulators, proteasome inhibitors and CD38 monoclonal antibodies)
Yakakodzera kiriniki miedzo uye data:
[Multi-center study] Nhamba yose yekuregererwa kwevarwere vose yaiva 72%, iyo iyo yakakwana yekuregererwa yaiva 28%; pakati pevarwere vakawana kuregererwa kwekiriniki yakakwana, 65% yevarwere vaive nekuregererwa kwakagara kwemwedzi inopfuura gumi nemaviri.
KTE-X19
(Brexucabtagene Autoleucel, Tecartus)
Mamiriro: Yakatenderwa kushambadzira (FDA)
Apo: Gumiguru 1, 2021
Introduction: A CAR-CD19 T cell therapy previously approved for the treatment of jasi cell lymphoma.
Zviratidzo: B lymphocytic leukemia (varwere vakuru vane relapsed uye refractory B lymphocytic leukemia)
Yakakodzera kiriniki miedzo uye data:
[ZUMA-3 trial] The complete remission rate was 56.4%, and 14.5% of patients achieved clinical complete remission. Only the blood counts did not return to normal, that is, CRi was achieved; the median progression-free survival was 11.6 months, and the median overall survival was 18.2 months. Patients who achieved clinical complete remission (including blood counts that did not return to normal) had a median progression-free survival of 14.2 months and had the shortest overall survival of 16.2 months; for those who did not, the median overall survival was only 2.4 months..
Yijililenxe Injection
(Aquilon Race; Yescarta, Axicabtagene Ciloleucel, Axi-Cel; FKC876)
Mamiriro: Yakatenderwa Kushambadzira (NMPA)
Panguva: Chikumi 23, 2021
Mutengo: 190,000 USD
Nhanganyaya: Chekutanga CAR-T cell chigadzirwa chakatangwa muChina iCAR-CD19-T cell therapy.
Kukosha: For adults with relapsed or refractory large B-cell lymphoma after receiving second-line or above standard therapy, this medicine is indicated. It can be used for diffuse large B-cell lymphoma unspecified, primary mediastinal B-cell carcinoma lymphoma tumarara, high-grade B-cell lymphoma, and diffuse large B-cell lymphoma transformed from follicular lymphoma.
Yakakodzera kiriniki miedzo uye data: [ZUMA-5 muedzo] Nhamba yemhinduro yose yakasvika 91%, uye chiyero chekupindura chakakwana chakanga chakakwirira se60%; nguva yepakati yekupindura haina kusvika pakutevera kwepakati pemwedzi ye14.5, uye 74% yevarwere vane nguva yekupindura inopfuura mwedzi ye18.
Ruiki Orenza Jekiseni
(Relma-cel, JWCAR029)
Mamiriro: Yakatenderwa Kushambadzira (NMPA)
Panguva: Gunyana 3, 2021
Mutengo: 200,000 USD
Nhanganyaya: Chechipiri CAR-T cell chigadzirwa chakatangwa muChina, uye zvakare yekutanga yepamba CAR-CD19-T kurapwa yakabvumidzwa zviri pamutemo kushambadzira, yakagadziriswa neShanghai WuXi Junuo.
Zviratidzo: Hombe B-cell lymphoma (varwere vakuru vane kudzokazve kana kuti refractory yakakura B-cell lymphoma mushure memutsara wechipiri kana pamusoro pechirongwa chekurapa)
Yakakodzera kiriniki miedzo uye data:
Huwandu hwekupindura hwese hwaive 60.3%.
Sidaki Aurexa Jekiseni
(LCAR-B38M, JNJ-4528, Cilta-cel, Carvykti)
Mamiriro: Yakatenderwa Kushambadzira (NMPA)
Apo: Kukadzi 28, 2022
Mutengo: US$465,000/tsono
Nhanganyaya: Chechitatu CAR-T cell chigadzirwa chakatangwa muChina ndeye CAR-BCMA-T kurapa kwakabatanidzwa kwakagadzirwa naJanssen uye Legend Bio.
Indications: Multiple myeloma (adult patients with relapsed/refractory multiple myeloma. Relevant clinical trials and data:
Nhamba yose yekupindura yaiva 98%, iyo 83% yevarwere vakawana mhinduro yakakwana yakakwana; Mwedzi we18 kufambira mberi-kusununguka kwekusununguka mwero waiva 66%, uye 2-gore kufambira mberi-kusununguka kwekusununguka mwero waiva 61%; mwero we18 wekupona kwese waive 81%, uye makore maviri-yese yekupona yaive 2%.
Pamusoro pezvigadzirwa zvakanyorwa pamusoro apa, kune zvakawanda zveCAR-T cell zvigadzirwa zviri mu pre-market nhanho, zvishoma nezvishoma kuunganidza data yekiriniki yekuedza, kana kuendesa chikumbiro chekushambadzira, uye ingori nhanho kubva kubva kumusangano zviri pamutemo nevarwere.
Among them, there are many “rookies” with potential as much as the marketed products, and during this period they have obtained various FDA licenses or “titles,” such as orphan drug designation, fast track qualification, advanced regenerative immune therapy, and so on.
Cilta-cel
(Ciltacabtagene autoleucel, domestic name: Ciltacabtagene autoleucel injection)
Mamiriro: (FDA) Yekutanga Ongororo
Zvinoratidza: Multiple myeloma (yakadzokazve/inoramba yakawanda myeloma)
Nhanganyaya: CAR-BCMA-T Cell Therapy
Yakakodzera kiriniki miedzo uye data:
[CARTITUDE-1 muedzo] Nhamba yekupindura yose yaiva 98%, iyo 83% yevarwere vakawana mhinduro yakakwana yakakwana; Mwedzi we18 kufambira mberi-kusununguka kwekusununguka mwero waiva 66%, uye 2-gore kufambira mberi-kusununguka kwekusununguka mwero waiva 61%; mwero we18 wekupona kwese waive 81%, uye makore maviri-yese yekupona yaive 2%.
ALLO-715
Mamiriro: (FDA) RMAT Dhizaini, Nherera Mushonga Dhizaini
Zvinoratidza: Multiple myeloma (yakadzokazve/inoramba yakawanda myeloma)
Nhanganyaya: CAR-BCMA-T Cell Therapy
Yakakodzera kiriniki miedzo uye data:
UNIVERSAL kuyedza: Muvarwere vakagamuchira 3.2 × 10 ^ 6 (320 miriyoni) CAR-T cell infusions, iyo yakazara mhinduro mwero yakasvika 60%. Nhamba yepakati pemitsara yekurapa yevarwere yaive 5.
Kymriah
(Tisagenlecleucel)
Mamiriro: (FDA) Yekutanga Ongororo yeZviratidzo Zvitsva
Zviratidzo: follicular lymphoma (yechipiri-mutsara kana pamusoro pekurapa kwekudzokazve kana refractory follicular lymphoma)
Nhanganyaya: CAR-CD19-T cell therapy, yakatenderwa kuvarwere vakuru vane kudzokazve / refractory yakakura B-cell lymphoma.
Yakakodzera kiriniki miedzo uye data:
[JULIET trial] The overall remission rate of 613 patients was 57.4%, of which 42.4% were in complete remission.
CTX110
Mamiriro: (FDA) RMAT zita
Zviratidzo: B-cell malignancies (yakadzokororwa kana refractory CD19-positive B-cell malignancies)
Nhanganyaya: Allogeneic CAR-CD19-T Cell Therapy
Yakakodzera kiriniki miedzo uye data:
[CARBON Trial] Among 24 patients who met the intention-to-treat criteria, the overall response rate of CTX110 in the second dose group was 58%, including 38% of patients who achieved a clinically complete response.
CT120
Mamiriro: (FDA) Nherera Zvinodhaka Zita
Chiratidzo: acute lymphoblastic leukemia
Introduction: CD19/CD22 Dual Targeting Chimeric Antigen Receptor (CAR) T Cell Therapy
C-CAR039
Mamiriro: (FDA) RMAT Dhizaini, Fast Track
Zviratidzo: Kuparadzira hombe B-cell lymphoma
Nhanganyaya: CD19/CD20 Dual Targeting Chimeric Antigen Receptor-T Cell Therapy
Yakakodzera kiriniki miedzo uye data:
【Pase I kuyedzwa】 Huwandu hwekudavirwa kwevarwere vane kudzokazve kana kuti refractory diffuse hombe B-cell lymphoma yaive 91.7%, iyo mhinduro yakakwana yaive 83.3%.
CT103A
Mamiriro: (FDA) Nherera Zvinodhaka Zita
Chiratidzo: multiple myeloma
Nhanganyaya: CAR-BCMA-T Cell Therapy
Yakakodzera kiriniki miedzo uye data:
[Phase I muedzo] Pakati pevarwere ve18 vane kudzokazve uye / kana kuti refractory multiple myeloma, huwandu hwekupindura kweCT103A hwakanga huri 100%, iyo 72.2% yevarwere yakasvika pachiyero chemhinduro yakakwana; iyo 1-gore kufambira mberi-yemahara mwero wekupona yaive 58.3 %.
Liso-Cel
(Lisocabtagene maraleucel, Breyanzi)
Mamiriro: (FDA) Yekutanga Ongororo, yakagamuchira chikumbiro chemvumo yekushambadzira
Nhanganyaya: CAR-CD19-T Cell Therapy
Chiratidzo: Yakakura B-cell lymphoma (varwere vakuru vane kudzokazve kana kuti refractory yakakura B-cell lymphoma avo vakakundikana mutsara wekutanga kurapwa)
So far, all CAR-T cell therapies that have been marketed have targeted various types of hematological tumors. Even if promising therapies are included, there are very few projects targeting solid tumors. It is so difficult for CAR-T therapy to break through solid tumors, and only a few “elites” can be on this most difficult “battlefield.”.
CT041
Mamiriro: (FDA) RMAT Dhizaini, Nherera Mushonga Dhizaini
Indications: Gastric cancer (Claudin18.2 positive advanced gastric cancer and gastroesophageal junction adenocarcinoma)
Nhanganyaya: CAR-Claudin 18.2-T Cell Therapy
Yakakodzera kiriniki miedzo uye data:
Nhamba yose yekupindura yevarwere vose yaiva 48.6%, uye chirwere chekudzivirira chirwere chaiva 73%; huwandu hwekupindura kwevose varwere vegomarara remudumbu hwaive 57.1%. Huwandu hwekupindura kwevarwere vegomarara remudumbu vaive vakundikana kanenge 2 mitsetse yekurapa munguva yakapfuura yaive 61.1%, uye chirwere chekudzora chirwere chaive 83.3%.
There is no doubt that CT041 is one of the most advanced and effective regimens among all CAR-T cell therapies for solid tumors. At present, this program is still recruiting subjects, and patients who have the opportunity to try it must not miss it!
AIC100
Mamiriro: (FDA) Fast Track
Zviratidzo: Chirwere chetachiona (anaplastic thyroid cancer and refractory, poorly differentiated thyroid cancer)
Nhanganyaya: CAR-ICAM-1-T Cell Therapy
There are three CAR-T products currently listed in China: one is 1.2 million per injection, the other is 1.29 million per injection, and the third is US$465,000 per injection. For the vast majority of patients, i’s an unbearable price.
The cost of CAR-T therapy is obviously expensive, but at the same time, my country is the country with the largest number of CAR-T cell therapy research and clinical trials, and a large number of domestic centers are recruiting Chinese patients for trial projects. For patients who meet the needs of the indication, this is a good channel to enjoy new drug treatments in advance and avoid huge expenses.
