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|Therapy Name||axicabtagene ciloleucel|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|axicabtagene ciloleucel||Yescarta||KTE-C19 CAR|KTE-C19||Yescarta (axicabtagene ciloleucel) is an immunotherapy consisted of peripheral T-lymphocytes engineered to express a chimeric antigen receptor targeting CD19, CD28 and CD3zeta, resulting in immunostimulating and antineoplastic activities (PMID: 32401634). Yescarta (axicabtagene ciloleucel) is FDA approved for adult patients with relapsed or refractory large B-cell lymphoma who have received two or more lines of therapies, including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma, and for adult patients with relapsed or refractory follicular lymphoma is not indicated for patients who have received two or more lines of therapies, but is not indicated for patients with primary central nervous system lymphoma (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT02625480||Phase Ib/II||axicabtagene ciloleucel||A Multi-Center Study Evaluating KTE-C19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-4)||Recruiting||USA | CAN||6|
|NCT03624036||Phase Ib/II||Cyclophosphamide + Fludarabine axicabtagene ciloleucel||Safety and Efficacy of KTE-C19 in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia (ZUMA-8)||Active, not recruiting||USA||1|
|NCT03391466||Phase III||axicabtagene ciloleucel||A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)||Active, not recruiting||USA | CAN||12|
|NCT02614066||Phase Ib/II||axicabtagene ciloleucel||A Study Evaluating KTE-C19 in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-3) (ZUMA-3)||Active, not recruiting||USA | CAN||3|
|NCT05041309||Phase II||KITE-585 KITE-222 Brexucabtagene autoleucel KITE-718 axicabtagene ciloleucel KITE-439||Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells||Enrolling by invitation||USA||0|
|NCT03105336||Phase II||axicabtagene ciloleucel||A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (ZUMA-5)||Active, not recruiting||USA||1|
|NCT04531046||Phase II||axicabtagene ciloleucel||Axi-Cel as a 2nd Line Therapy in Patients With Relapsed/Refractory Aggressive B Lymphoma Ineligible to Autologous Stem Cell Transplantation||Recruiting||2|
|NCT04608487||Phase I||Cyclophosphamide + Fludarabine axicabtagene ciloleucel||Axi-cel in CNS Lymphoma||Recruiting||USA||0|
|NCT02348216||Phase Ib/II||axicabtagene ciloleucel||A Phase 1-2 Multi-Center Study Evaluating KTE-C19 in Subjects With Refractory Aggressive Non-Hodgkin Lymphoma (ZUMA-1)||Active, not recruiting||USA | CAN||4|