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Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy

StatusRecruiting
PhasePhase 3
Started2026-05-22
View on ClinicalTrials.gov ↗

Amendment history

2026-09-03
Study Status, Contacts/Locations v7
Trial sites expanded: 14 → 19 locations
2026-08-10
Study Status, Contacts/Locations v6
Trial sites expanded: 10 → 14 locations
2026-07-14
Study Status, Contacts/Locations v5
Trial sites expanded: 2 → 10 locations
2026-06-15
Study Status, Contacts/Locations v4
Start dateestimated 2026-08→confirmed 2026-05-22
Study sites1→2
2026-05-11
Study Status, Contacts/Locations v3
Recruitment opened
Study sites0→1
Show 2 earlier versions
2026-04-17
Study Status v2
Re-verified, no change to tracked fields
2026-03-26
Study Status, Study Description, Conditions, Arms and Interventions, Eligibility, References v1
Eligibility criteria-19 characters
Key Inclusion Criteria: 1) Individuals with any of the following large B-cell lymphomas [...] investigator, are eligible for the study as defined below: WhoWorld Health Organization (WHO): i. Individuals with chemorefractory disease to first-line thera [...] s 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 [...] [...]
2026-03-13
Original filing
Gilead Sciences
107 trials monitored
See 8 trials at risk
Non-Hodgkin Lymphoma
1,512 trials monitored
See 79 trials at risk
DLBCL
648 trials monitored
See 32 trials at risk
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.
Trial Details
NCT Number NCT07479797
Lead Sponsor Kite, A Gilead Company
Conditions Relapsed or Refractory Large B-cell Lymphoma
Enrollment 550 participants
Start Date 2026-05-22
Primary Completion 2031-05 (estimated)
Study Completion 2031-05 (estimated)
Updated on ClinicalTrials.gov 2026-09-04