ມີນາ 2022: ຫຼັງຈາກການປິ່ນປົວກ່ອນ 38 ເສັ້ນ, ລວມທັງຕົວຍັບຍັ້ງ proteasome (PI), ຕົວແທນ immunomodulatory (IMiD), ແລະ anti-CDXNUMX monoclonal antibody, ອົງການອາຫານແລະຢາໄດ້ອະນຸມັດ ciltacabtagene autoleucel. (CARVYKTI, Janssen Biotech, Inc.) ສໍາລັບການປິ່ນປົວຂອງຄົນເຈັບຜູ້ໃຫຍ່ທີ່ມີ myeloma ຫຼາຍ relapsed ຫຼື refractory.
Ciltacabtagene autoleucel ເປັນ autologous chimeric antigen receptor CAR ທີ່ໄດ້ຮັບການອອກແບບທາງພັນທຸກໍາ ການປິ່ນປົວການປິ່ນປົວດ້ວຍ T-cell ທີ່ເປົ້າຫມາຍ antigen ແກ່ B-cell (BCMA). ແຕ່ລະຄັ້ງແມ່ນເຫມາະສົມກັບ T-cells ຂອງຄົນເຈັບເອງ, ເຊິ່ງໄດ້ຖືກຂຸດຄົ້ນ, ດັດແປງພັນທຸກໍາ, ແລະຫຼັງຈາກນັ້ນນໍາມາໃຫມ່ໃນຄົນເຈັບ.
CARTITUDE-1 (NCT03548207) was an open label, multicenter ການທົດລອງທາງດ້ານການຊ່ວຍ that looked at the safety and efficacy of ciltacabtagene autoleucel in 97 patients with relapsed or refractory myeloma ຫຼາຍ who had received at least three prior lines of therapy, including a PI, an IMiD, and an anti-CD38 monoclonal antibody, and who had disease progression on or after the last chemotherapy regimen Patients were given 0.51.0106 CAR-positive viable T cells per kg body weight of ciltacabtagene autoleucel. Efficacy was determined by an Independent Review committee utilising the International Myeloma Working Group Uniform Response Criteria for Multiple Myeloma to assess overall response rate (ORR) and duration of response (DOR). The ORR was 97.9% (95 percent confidence interval: 92.7 percent, 99.7%). The median duration of response (DOR) was 21.8 months (95 percent CI: 21.8, NE) among the 95 patients who responded, with a median follow-up period of 18 months.
The CARVYKTI label includes a boxed warning for ໂຣກການປ່ອຍ cytokine (CRS), hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Parkinsonism and Guillain-Barré syndrome and their complications, and prolonged and/or recurrent cytopenia, which can all be fatal or life-threatening. Pyrexia, cytokine release syndrome, hypogammaglobulinemia, musculoskeletal pain, fatigue, infections, diarrhoea, nausea, encephalopathy, headache, coagulopathy, constipation, and vomiting were the most prevalent side effects of ciltacabtagene autoleucel.
CARVYKTI ມີການປະເມີນຄວາມສ່ຽງແລະແຜນການຫຼຸດຜ່ອນທີ່ຮຽກຮ້ອງໃຫ້ໂຮງຫມໍແລະຄລີນິກທີ່ແຈກຢາຍການປິ່ນປົວໄດ້ຮັບການຢັ້ງຢືນໂດຍສະເພາະເພື່ອຮັບຮູ້ແລະແກ້ໄຂ CRS ແລະສານພິດຂອງລະບົບປະສາດ. FDA ກໍາລັງຂໍໃຫ້ບໍລິສັດດໍາເນີນການສຶກສາການສັງເກດການຫລັງການຕະຫຼາດທີ່ກ່ຽວຂ້ອງກັບຄົນເຈັບທີ່ໄດ້ຮັບການປິ່ນປົວດ້ວຍ ciltacabtagene autoleucel ເພື່ອປະເມີນຄວາມປອດໄພໃນໄລຍະຍາວ.
CARVYKTI ແມ່ນໃຫ້ໃນປະລິມານ 0.5-1.0106 CAR-positive viable T-cells ຕໍ່ກິໂລຂອງນ້ໍາຫນັກຕົວ, ໂດຍປະລິມານສູງສຸດແມ່ນ 1108 CAR-positive viable T-cells ຕໍ່ infusion.
