Maris 2022: CAR-T far, fasahar CAR-T, menene CAR-T cell rigakafin rigakafi ? Farashin jiyya na CAR-T, farashi, sabuwar bayanan daukar ma'aikata na CAR-T na asibiti.
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 far ya kuma wuce shekaru da yawa, amma tun bara, musamman tun daga rabin na biyu na bara, adadi mai yawa CAR-T hanyoyin kwantar da hankali have been “combined.”. Anti-cancer “new forces” are rapidly emerging.
Emily Whitehead, yaro na farko da ke fama da cutar sankarar bargo da aka yi masa magani CAR-T far da kuma "mai magana da yawun" na CAR-T far, ya ci cutar sankarar bargo kusan shekaru goma. Yanzu wannan "abin al'ajabi" a ƙarshe ya zo mata a kusa da marasa lafiyar mu.
Daga 2021 zuwa yanzu, maganin CAR-T ya nuna yanayin tarawa, kuma an ƙaddamar da samfuran da yawa ɗaya bayan ɗaya. A cikin wannan lokacin, ƙasata ta ƙaddamar da hanyoyin kwantar da hankali na CAR-T guda 3 a jere, yana ba marasa lafiya damar ganin farkon sabon shiri.
Liso-Cel
(Lisocabtagene maraleucel, Breyanzi)
Matsayi: An Amince don Talla (FDA)
Lokacin: Fabrairu 6, 2021
Gabatarwa: Liso-Cel maganin anti-CD19 ne wanda ya danganci ƙwayoyin T na majiyyaci.
Indications: Large B-cell linzoma (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)
Rahoto gwaji na asibiti da data:
[TRANSCEND NHL 001 gwaji (NCT02631044)] Ga marasa lafiya da aka bi da su tare da Liso-Cel, adadin gafarar gabaɗaya shine 73%, wanda cikakken adadin gafara ya kai 53%; marasa lafiya na iya samun gafarar farko ko juzu'i bayan kusan wata 1 na jiyya.
A matsakaicin matsakaici na watanni 12, 54.7% na marasa lafiya sun kasance a cikin asibiti; marasa lafiya suna da tsaka-tsaki na rayuwa marasa kyauta na watanni 6.8 da matsakaicin rayuwa na watanni 21.1; marasa lafiya sun sami adadin rayuwa na shekara 1 na 58%.
Axi-Cel
(Axicabtagene ciloleucel, Yescarta)
Matsayi: An Amince don Talla (FDA)
Lokacin: Maris 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 rigakafin rigakafi domin follicular lymphoma.
Alamomi: Lymphoma follicular (sake dawowa ko refractory follicular lymphoma, manya marasa lafiya, bayan biyu ko fiye na tsarin jiyya)
Rahoto gwaji na asibiti da data:
[gwajin ZUMA-5] Yawan amsa gabaɗaya ya kai 91%, kuma cikakkiyar ƙimar amsa ta kai 60%; Ba a kai ga tsawon lokacin amsawa ba a cikin tsaka-tsakin watanni na 14.5, kuma 74% na marasa lafiya suna da lokacin amsawa fiye da watanni 18.
Matsayi: An Amince don Talla (FDA, Lasisin Ƙarin Halittu)
Nunawa: Tsarin tsari mai girma don jiyya na layi na biyu na manya marasa lafiya tare da relapsed / refractory B-cell lymphoma
Ide-cel
(Idecabtagene vicleucel, Abecma)
Matsayi: An Amince don Talla (FDA)
Lokacin: Maris 26, 2021
Gabatarwa: Abecma mai sarrafa kansa ne wanda ke jagorantar BCMA chimeric antigen receptor (CAR) T cell far wanda aka keɓance daga sel T masu sarrafa kansa na majiyyaci.
Shaidawa: Mye 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)
Abubuwan da suka dace na gwaji da bayanai:
[Nazarin ci gaba da yawa] Jimlar yawan gafarar duk marasa lafiya shine 72%, wanda cikakken adadin gafara shine 28%; daga cikin marasa lafiya da suka sami cikakkiyar gafara na asibiti, 65% na marasa lafiya sun sami gafara wanda ya wuce fiye da watanni 12.
KTE-X19
(Brexucabtagene Autoleucel, Tecartus)
Matsayi: An Amince don Talla (FDA)
Lokacin: Oktoba 1, 2021
Introduction: A CAR-CD19 T cell therapy previously approved for the treatment of maganin sutturar ƙwayar sel.
Alamomi: B lymphocytic cutar sankarar bargo (manyan marasa lafiya tare da relapsed da refractory B lymphocytic cutar sankarar bargo)
Abubuwan da suka dace na gwaji da bayanai:
[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 Allurar
(Aquilon Race; Yescarta, Axicabtagene Ciloleucel, Axi-Cel; FKC876)
Matsayi: An Amince don Talla (NMPA)
Lokacin: Yuni 23, 2021
Farashin: 190,000 USD
Gabatarwa: Samfurin salula na farko na CAR-T da aka ƙaddamar a China shine CAR-CD19-T cell far.
Muhimmancin: 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 tumo, high-grade B-cell lymphoma, and diffuse large B-cell lymphoma transformed from follicular lymphoma.
Abubuwan da suka dace na gwaji da bayanai: [gwajin ZUMA-5] Yawan amsa gabaɗaya ya kai 91%, kuma cikakkiyar ƙimar amsa ta kai 60%; Ba a kai ga tsawon lokacin amsawa ba a cikin tsaka-tsakin watanni na 14.5, kuma 74% na marasa lafiya suna da lokacin amsawa fiye da watanni 18.
Ruiki Orenza Allura
(Relma-cel, JWCAR029)
Matsayi: An Amince don Talla (NMPA)
Lokacin: Satumba 3, 2021
Farashin: 200,000 USD
Gabatarwa: Samfurin tantanin halitta na CAR-T na biyu da aka ƙaddamar a kasar Sin, da kuma maganin CAR-CD19-T na gida na farko da aka amince da shi a hukumance don tallatawa, Shanghai WuXi Junuo ne ya ƙera shi.
Alamomi: Large B-cell lymphoma (manyan marasa lafiya tare da relapsed ko refractory babban B-cell lymphoma bayan layi na biyu ko sama tsarin far)
Abubuwan da suka dace na gwaji da bayanai:
Yawan amsa gabaɗaya ya kasance 60.3%.
Sidaki Aurexa allura
(LCAR-B38M, JNJ-4528, Cilta-cel, Carvykti)
Matsayi: An Amince don Talla (NMPA)
Lokacin: Fabrairu 28, 2022
Farashin: US $ 465,000 / allura
Gabatarwa: Samfurin tantanin halitta na uku na CAR-T da aka ƙaddamar a China shine maganin CAR-BCMA-T wanda Janssen da Legend Bio suka haɓaka tare.
Indications: Multiple myeloma (adult patients with relapsed/refractory multiple myeloma. Relevant clinical trials and data:
Yawan amsa gabaɗaya shine 98%, wanda 83% na marasa lafiya sun sami cikakkiyar amsa; Adadin tsira na watanni 18 ba tare da samun ci gaba ba shine 66%, kuma adadin tsira na shekaru 2 ba tare da samun ci gaba ba shine 61%; jimlar adadin rayuwa na watanni 18 ya kasance 81%, kuma adadin tsira na shekara 2 ya kasance 74%.
Baya ga samfuran da aka lissafa a sama, akwai ƙarin samfuran tantanin halitta na CAR-T waɗanda ke cikin matakin farko na kasuwa, a hankali suna tattara bayanan gwaji na asibiti, ko kuma sun ƙaddamar da aikace-aikacen tallace-tallace, kuma sun yi nesa da saduwa da marasa lafiya a hukumance.
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)
Matsayi: (FDA) Bita na Farko
Alamomi: Multiple myeloma (sake dawowa/mahara myeloma mai yawa)
Gabatarwa: CAR-BCMA-T Kwayoyin Kwayoyin cuta
Abubuwan da suka dace na gwaji da bayanai:
[CARTITUDE-1 gwaji] Yawan amsa gabaɗaya shine 98%, wanda 83% na marasa lafiya sun sami cikakkiyar amsa; Adadin tsira na watanni 18 ba tare da samun ci gaba ba shine 66%, kuma adadin tsira na shekaru 2 ba tare da samun ci gaba ba shine 61%; jimlar adadin rayuwa na watanni 18 ya kasance 81%, kuma adadin tsira na shekara 2 ya kasance 74%.
ALLO-715
Matsayi: (FDA) Tsarin RMAT, Zayyana Magungunan Marayu
Alamomi: Multiple myeloma (sake dawowa/mahara myeloma mai yawa)
Gabatarwa: CAR-BCMA-T Kwayoyin Kwayoyin cuta
Abubuwan da suka dace na gwaji da bayanai:
Gwajin UNIVERSAL: A cikin marasa lafiya da suka karbi 3.2 × 10 ^ 6 (miliyan 320) CAR-T cell infusions, yawan amsawar amsa ya kai 60%. Matsakaicin adadin layukan jiyya ga marasa lafiya 5 ne.
Kimiya
(Tisagenlecleucel)
Matsayi: (FDA) Bita na fifiko don Sabbin Alamu
Alamomi: lymphoma follicular (layi na biyu ko sama da jiyya na relapsed ko refractory follicular lymphoma)
Gabatarwa: CAR-CD19-T cell far, yarda ga manya marasa lafiya tare da relapsed/refractory babban B-cell lymphoma
Abubuwan da suka dace na gwaji da bayanai:
[JULIET trial] The overall remission rate of 613 patients was 57.4%, of which 42.4% were in complete remission.
Saukewa: CTX110
Matsayi: (FDA) RMAT nadi
Alamomi: Malignancies na B-cell (sake dawowa ko rashin lafiyar CD19-tabbatacce B-cell malignancies)
Gabatarwa: Allogeneic CAR-CD19-T Cell Therapy
Abubuwan da suka dace na gwaji da bayanai:
[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
Matsayi: (FDA) Zayyana Magungunan Marayu
Bayyanawa: m lymphoblastic cutar sankarar bargo
Introduction: CD19/CD22 Dual Targeting Chimeric Antigen Receptor (CAR) T Cell Therapy
C-CAR039
Matsayi: (FDA) Tsarin RMAT, Hanyar sauri
Alamomi: Yada manyan B-cell lymphoma
Gabatarwa: CD19/CD20 Dual Targeting Chimeric Antigen Receptor-T Cell Therapy
Abubuwan da suka dace na gwaji da bayanai:
【Mataki na I gwaji】 Gabaɗayan ƙimar amsawar marasa lafiya tare da babban ƙwayar lymphoma mai girma na B-cell ya kasance 91.7%, wanda cikakken ƙimar amsa ya kasance 83.3%.
Saukewa: CT103A
Matsayi: (FDA) Zayyana Magungunan Marayu
Alamomi: mahara myeloma
Gabatarwa: CAR-BCMA-T Kwayoyin Kwayoyin cuta
Abubuwan da suka dace na gwaji da bayanai:
[Tsarin I na gwaji] Daga cikin marasa lafiya na 18 tare da sake dawowa da / ko refractory mahara myeloma, yawan amsawar CT103A shine 100%, wanda 72.2% na marasa lafiya sun kai ma'auni na cikakkiyar amsa; Adadin rayuwa ba tare da ci gaba na shekara 1 ya kasance 58.3%.
Liso-Cel
(Lisocabtagene maraleucel, Breyanzi)
Matsayi: (FDA) Bita na fifiko, ya karɓi aikace-aikacen don amincewar tallace-tallace
Gabatarwa: CAR-CD19-T Salon Farko
Nunawa: Large B-cell lymphoma (manyan marasa lafiya tare da relapsed ko refractory babban B-cell lymphoma wadanda suka kasa farfagandar farko)
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
Matsayi: (FDA) Tsarin RMAT, Zayyana Magungunan Marayu
Indications: Gastric cancer (Claudin18.2 positive advanced gastric cancer and gastroesophageal junction adenocarcinoma)
Gabatarwa: CAR-Claudin 18.2-T Cell Therapy
Abubuwan da suka dace na gwaji da bayanai:
Matsakaicin yawan amsawar dukkan marasa lafiya shine 48.6%, kuma adadin kula da cutar shine 73%; jimlar yawan amsawar duk masu fama da ciwon daji na ciki shine 57.1%. Yawan amsa gaba ɗaya na masu ciwon daji na ciki waɗanda suka gaza aƙalla layin 2 na jiyya a baya shine 61.1%, kuma adadin kula da cutar ya kasance 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!
Saukewa: AIC100
Matsayi: (FDA) Hanyar sauri
Shaidawa: Ciwon daji na thyroid (anaplastic thyroid cancer and refractory, poorly differentiated thyroid cancer)
Gabatarwa: CAR-ICAM-1-T Salon Farko
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.
