Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Rel… (NCT07479797) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy
550 participantsStarted 2026-08
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Key Inclusion Criteria:
* Individuals with any of the following large B-cell lymphomas, as determined by the investigator, are eligible for the study as defined below:
* World Health Organization (WHO):
* Individuals with chemorefractory disease to first-line therapy (primary refractory disease) that satisfies any of the following criteria:
* 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.
* Individuals with relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven disease relapsed ≤ 12 months of completion of first-line therapy.
* Note: If the relapse is confirmed by imaging per International Working Group (IWG) Lugano Response Criteria for Malignant Lymphoma within 12 months, the confirmatory biopsy must be performed within 90 days of the 12-month cutoff.
* Prior therapy must have included an anti-CD20 antibody (including CD20-targeting T-cell engager antibodies) and an anthracycline-containing chemotherapy re…
What they're measuring
1
Proportion of Participants in Complete Response (CR) at Month 6