PALISADES-2
Research type
Research Study
Full title
A Phase 3, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants with Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy.
IRAS ID
1013618
Contact name
Carlos Gonzalez Arias
Contact email
Sponsor organisation
Kite Pharma, Inc.
Clinicaltrials.gov Identifier
Research summary
The purpose of the KT‑US‑740‑0603 study, sponsored by Kite Pharma Inc., is to find out whether an experimental treatment called KITE‑753 is safe and effective for treating large B‑cell lymphoma (LBCL). This study will compare KITE‑753 with axicabtagene ciloleucel, referred to as “axi‑cel”. Axi‑cel is the same treatment as the approved medicine Yescarta®.
Participants in this study have relapsed or refractory LBCL and standard therapies available to treat this disease have limited effectiveness. Both treatments used in this study are made from the participants own white blood cells, called T cells. These cells are collected from the participant, genetically modified to target their cancer cells, and given back to the participant as a one time infusion into a vein (intravenously). Participants will be randomly assigned to receive either axi‑cel or KITE‑753, with an equal chance (1:1) ratio.
Participants will go through the following steps: Leukapheresis – a procedure to collect white blood cells from the blood; Optional bridging therapy – short‑term treatment that may be given if the cancer is growing quickly; Lymphodepletion chemotherapy – chemotherapy given before the study treatment to prepare the body; Study treatment infusion of either axi‑cel or KITE‑753. The infusion will take place in a hospital or treatment facility. Participants will be admitted or closely monitored as an outpatient for at least 7 days after the infusion.
About 550 participants at around 150 study sites will participate in the study.
Participants may be on this study for at least 3 years after which they will be asked to transfer to a separate Long-Term Follow-Up (LTFU) study. This LTFU study will monitor their health for up to 15 years.
Study procedures include questionnaires, vital signs, physical and neurological examinations, tumour sample collection, blood/urine sample collection, lumbar puncture, electrocardiograms (ECGs), imaging scans (e.g. CT, PET-CT, MRI, ECHO/MUGA).REC name
North East - York Research Ethics Committee
REC reference
26/NE/0050
Date of REC Opinion
20 Apr 2026
REC opinion
Further Information Favourable Opinion