Dec 2020: Jami'ar Texas MD Anderson Masu bincike na Cibiyar Cancer sun gano cewa axi-cel, wani autologous anti-CD19 chimeric antigen receptor (CAR) T cell therapy, lafiya ne kuma mai inganci maganin layin farko ga marasa lafiya tare da babban haɗarin babban lymphoma B-cell. (LBCL), ƙungiyar da ke cikin matsananciyar buƙatar sabbin jiyya masu inganci.
An gabatar da waɗannan binciken ne a taron shekara-shekara na 2020 na Society of Hematology na Amurka.
Traditionally, around half of patients with high-risk LBCL, a subgroup of the disease in which patients have double- or triple-hit linzoma or additional clinical risk factors identified by the International Prognostic Index (IPI), have not achieved long-term disease remission with standard treatment approaches such as chemoimmunotherapy.
This trial represents a step toward making CAR T cell far a first-line treatment option for patients with aggressive B-cell lymphoma,” said Sattva S. Neelapu, M.D., professor of Lymphoma and Myeloma. “At the moment, patients with newly diagnosed aggressive B-cell lymphoma get chemotherapy for about six months. CAR T cell far, if successful, may make it a one-time infusion with treatment completed in one month.
Dangane da mahimmin bincike na ZUMA-1, Axi-cel yana da lasisi a halin yanzu don kula da mutanen da ke da LBCL da suka koma baya ko kuma sun riga sun sami layi biyu ko fiye na tsarin jiyya. Gwajin ZUMA-12 shine alamar buɗewa na Phase 2, hannu ɗaya, gwaji mai yawa wanda ya gina akan binciken da aka yi na gwajin ZUMA-1 don tantance amfani da axi-cel a matsayin jiyya na farko ga marasa lafiya tare da babban haɗarin LBCL. .
Bisa ga binciken wucin gadi na ZUMA-12, kashi 85 cikin 74 na marasa lafiya da aka yi musu magani tare da axi-cel sun sami amsa gabaɗaya, kuma 9.3% sun sami cikakkiyar amsa. Bayan bin tsaka-tsaki na watanni 70, XNUMX% na marasa lafiya da aka ɗauka sun nuna ci gaba da amsawa a yanke bayanan.
White blood cell count reduction, encephalopathy, anaemia, and cytokine saki ciwo were the most common side effects linked with axi-cel treatment. By the time the data was analysed, all adverse events had been resolved.
Furthermore, when compared to when the immunotherapy products were generated from patients who had already received several lines of chemotherapy, the peak level of CAR T cells present in the blood, as well as the median CAR T cell expansion, were higher in this trial of first-line CAR T cell far.
Neelapu ya kara da cewa "Wannan lafiyar tantanin halitta ta T tana iya haɗawa da mafi girman tasirin warkewa, wanda ke haifar da mafi kyawun sakamakon haƙuri."
Bayan kyakkyawan sakamako na wucin gadi na ZUMA-12, masu binciken sun yi shirin ci gaba da bin diddigin majiyyatan don tabbatar da cewa halayensu na maganin sun dade.
“A randomised clinical trial would be required to definitely demonstrate that CAR T cell therapy is superior to existing standard of care with chemoimmunotherapy in these high-risk patients if the responses are persistent after prolonged follow-up,” Neelapu said. It also begs the question of whether CAR T cell treatment should be tested in intermediate-risk patients with big B-cell lymphoma.