The goal of this clinical study is to compare the study drug KITE-753 versus axicabtagene ciloleucel (axi-cel) in adult participants with relapsed or refractory (r/r) large B-cell lymphoma (LBCL) after one prior line of therapy.
The primary objective of this study is to evaluate the efficacy of KITE-753 versus axicabtagene ciloleucel.
Progressive disease (PD) and/or Deauville score of 5 (irrespective of the response designation) as the best response during the first-line treatment or as the end of treatment response following first-line therapy.
Stable disease (SD) after at least 4 cycles of first-line therapy (eg, 4 cycles of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)).
PR as best response after at least 6 cycles of first-line therapy (eg, 6 cycles of R-CHOP).
Note: A biopsy is recommended to confirm residual disease.
Prior CAR T-cell therapy or other cell-based therapy.
History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, or breast) unless disease-free and without anti-cancer therapy (with the exception of hormonal therapy in the case of breast cancer) for at least 3 years. Individuals with asymptomatic localized low-grade prostate cancer for which a watch-and-wait approach is standard of care are eligible.
Individuals with the following LBCL fifth edition of WHO criteria subtypes: Richter's transformation of chronic leukemic lymphoma, small lymphocytic lymphoma, Burkitt lymphoma, lymphoplasmacytic lymphoma, T-cell/histiocyte-rich LBCL, mediastinal gray zone lymphoma, plasmablastic lymphoma, intravascular LBCL, primary central nervous system (CNS) lymphoma, primary vitreoretinal LBCL, fibrin-associated LBCL, fluid overload-associated LBCL lymphomatoid granulomatosis, high-grade B-cell lymphoma (HGBCL) with 11q aberrations, anaplastic lymphoma kinase-positive LBCL, LBCL with Interferon Regulatory Factor 4 (IRF4) rearrangement, and transformed from Hodgkin's lymphoma (HL). Note: Individuals with primary testicular LBCL are eligible.
History of a severe, immediate hypersensitivity reaction attributed to aminoglycosides
Parallel
KITE-753
DrugA single infusion of CAR-transduced autologous T cells administered as intravenous infusion.
Axicabtagene Ciloleucel
DrugA single infusion of CAR-transduced autologous T cells administered as intravenous infusion.
Fludarabine
DrugAdministered intravenously
Cyclophosphamide
DrugAdministered intravenously
Proportion of Participants in Complete Response (CR) at Month 6
Participants who would be in CR at Month 6 postinfusion of KITE-753 or axi-cel and prior to subsequent anti-lymphoma therapy. This will be assessed by the Lugano Classification by the blinded central assessment.
Event-free survival (EFS)
EFS is defined as the time from randomization to the earliest occurrence of the following EFS events: a) Death due to any cause, b) Disease progression/relapse per blinded central assessment, and c) Initiation of any non-protocol specified subsequent anti-lymphoma therapy for the treatment of residual disease (including stable disease and partial response as per International Working Group (IWG) Lugano Response Criteria for Malignant Lymphoma).
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have achieved either CR or partial response (PR) by the Lugano Classification as determined by blinded central assessment after treatment completion and prior to subsequent anti-lymphoma therapy.
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to disease progression per the Lugano Classification as determined by blinded central assessment or death from any cause.
Duration of Response (DOR)
DOR is defined as the time from first objective response (CR or PR) prior to subsequent anti-lymphoma therapy to disease progression or death from any cause.
Duration of Complete Response (DOCR)
DOCR is defined as the time from first CR prior to subsequent anti-lymphoma therapy to disease progression or death from any cause.
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