Phase 1_Safety & Efficacy of KITE-363 for Relapsed and/or Refractory B-cell Lymphoma_KT-US-499-0150
Research type
Research Study
Full title
A Phase 1 Open-label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19/CD20 CAR T-cell Therapy, in Subjects With Relapsed and/or Refractory B-cell Lymphoma
IRAS ID
1004974
Contact name
Lynsey Kennedy
Contact email
Sponsor organisation
Kite Pharma, Inc.
Eudract number
2020-000562-41
Clinicaltrials.gov Identifier
Research summary
The aim of this study is to evaluate how safe and effective the experimental drug, KITE-363 is in treating patients with relapsed and/or refractory B cell lymphoma.
This Phase 1 study is the first study of this experimental treatment in people. The study is being done in two steps, dose-escalation and dose-expansion:
• Dose-escalation means several dose levels may be studied to determine the most effective and safe dose(s). Safety and efficacy will be evaluated in people with different types of B-cell lymphoma.
• Dose-expansion will study the safety and effectiveness of the dose level(s) selected during dose-escalation.
KITE-363 is manufactured using participants own blood cells using leukapheresis, a procedure where blood is taken from them and is circulated through a machine that separates out the cells in their blood. During this procedure, white blood cells, including T cells (white blood cell that helps fight infection and cancer), are collected and then all other remaining cells and plasma are given back to the participant. The T cells that are collected will then be sent to a manufacturing facility to be genetically modified in order to make the experimental treatment called KITE-363. The genetic modification uses a virus (called a lentiviral vector) to introduce a pair of special receptors called a chimeric antigen receptor into the T cells, in a permanent way, so that the T cells can identify the tumour cells. The modified T cells are called “KITE 363”. These are given back to the participant through a needle in their vein. After KITE-363 is infused, the hope is that KITE-363 cells will target and kill their tumour cells.
Approximately 70 participants at 15 to 20 centres will participate in the study. Of these, approximately 30 will take part in the dose-escalation part of the study, and approximately 40 in the dose-expansion part.REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/LO/0354
Date of REC Opinion
4 Aug 2022
REC opinion
Further Information Favourable Opinion