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

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

First listed

Mar 18, 2026

Start date

May 22, 2026

Status verified

Sep 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

• Medical Information
  844-454-5483(1-844-454-KITE)
  [email protected]

Locations (14)

Find similar trials in Goodyear, AZ

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