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

Part of paid clinical trials in Stanford, California.

Sponsor
Kite, A Gilead Company
Study ID
NCT07479797
Phase
PHASE3
Status
Recruiting
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Conditions

  • Relapsed or Refractory Large B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KITE-753 — DRUG
    A single infusion of CAR-transduced autologous T cells administered as intravenous infusion.
  • Axicabtagene Ciloleucel — DRUG
    A single infusion of CAR-transduced autologous T cells administered as intravenous infusion.
  • Fludarabine — DRUG
    Administered intravenously
  • Cyclophosphamide — DRUG
    Administered intravenously

Study Details

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.

Key Dates

Start date
Aug 31, 2026
Status verified
May 2026
Primary completion
May 31, 2031
Completion
May 31, 2031

Study Design

Enrollment
550 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lymphodepleting Chemotherapy: KITE-753
    Participants with r/r LBCL will receive the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine and cyclophosphamide. * A single infusion at a target dose of anti-cluster of differentiation 19 (CD19)/CD20 chimeric antigen receptor (CAR) T cells/kg of KITE-753.
  • Experimental: Lymphodepleting Chemotherapy: Axicabtagene Ciloleucel (axi-cel)
    Participants with r/r LBCL will receive the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine and cyclophosphamide. * A single infusion at a target dose of anti-CD19/CD20 CAR T cells/kg of axi-cel.

Primary Outcome Measure

Proportion of Participants in Complete Response (CR) at Month 6 [ Time Frame: Month 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-

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By research site
Stanford University· Stanford, CA

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