Brexucabtagene Autoleucel in Adults with Rare B-cell Malignancies (ZUMA-25) – Substudy A
Research type
Research Study
Full title
A Phase 2, Open-Label, Multicenter, Basket Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel in Adults with Rare B-cell Malignancies (ZUMA-25) – Substudy A – Relapsed/Refractory Waldenstrom Macroglobulinemia
IRAS ID
1006194
Contact name
Olga Nikolajeva
Contact email
Sponsor organisation
Kite Pharma, Inc.
Research summary
Waldenstrom Macroglobulinemia (WM) is a rare blood cell cancer affecting the bone marrow. It is predominantly seen in older adults. There are no currently approved therapies that have curative potential with standard therapies available having limited effectiveness in treating this disease.
The purpose of this study is to find out if the experimental treatment, brexu-cel, is safe and effective in treating WM. Approximately 60 participants will take part globally.
Immunotherapy is a type of therapy that uses the body’s own immune system to target the tumour. Brexu-cel is manufactured using the patients own white blood cells. If patients meet study eligibility criteria they will undergo a procedure known as leukapheresis, this involves removing white blood cells from the blood. These cells are then modified so that they can more effectively identify and destroy tumor cells, and then returning those modified cells back to the patient via intravenous (IV) infusion and assessing the effect on their cancer cells. Prior to the infusion participants will undergo lymphodepleting chemotherapy in order to help brexu-cel work with less interference from the cells in the immune system. Patients must remain in hospital for 10 days following their infusion.
The study is open label meaning the treatment is known to both the study doctor and participant.
The study can be broken down into six distinct sections: screening, enrollment and leukapheresis, optional bridging therapy, lymphodepleting chemotherapy, treatment and post-treatment follow up. Participants will be followed up within the study for a duration of 60 months. Assessments to determine how participants are responding to treatment will occur at day 28, month 3, every 3 months up to month 12, every 6 months up to month 36 and then annually to month 60.REC name
London - West London & GTAC Research Ethics Committee
REC reference
23/LO/0002
Date of REC Opinion
21 Jul 2023
REC opinion
Further Information Unfavourable Opinion