CABRIO study: in depth analyses of the immune system during and after CAR T therapy to improve outcome (ALL)
Clinical study of the mechanism of CAR T-cell therapy and the impact of the immune system on CAR T-cell efficacy.
Recruiting
Who can enter
Children and young adults up to 25 years old treated with CAR T therapy in the Princess Máxima Center
Children that received CAR T therapy in another hospital and come to the Maxima for follow-up can also enter
The research focuses on the first year after CAR T-cell therapy
Goal
Goal
The goal of this research is to understand why CAR T-cell therapy is highly effective in only 50% of the patients.
Background
Background
Treatment options for relapsed and refractory B-cell leukemia in children have improved greatly since the introduction of immunotherapy. Treatment with CAR T-cells, a form of cell therapy in which the patient's own immune cells are targeted against the leukemia, has entered reimbursed care. In this form of cell therapy, the patient's immune cells are genetically altered outside the body so that they have an extra protein that can recognize and destroy the leukemia cells. To do this, the immune cells are first altered and then multiplied before being given back to the patient.
This is a new form of therapy whose long-term effects are not yet sufficiently known. We also do not yet know which patients will respond and which will not. If we understand this better, we will also be able to use the current therapy better.
In this study, we follow up children who are receiving CAR T-cell therapy. We do this by taking extra blood, bone marrow or cerebrospinal fluid several times during regular check-ups. This is not inconvenient for the children because we only do the withdrawals if blood, bone marrow or cerebrospinal fluid would also be taken for regular care. We also collect stool samples from these children.
As an additional examination, we ask if we can also take a bone biopsy (a small piece of bone) during a bone marrow puncture. The doctor will explain exactly what this means.
In order to participate in a study please refer to your/your child’s doctor.
Last reviewed
Last reviewed
September 23, 2025
Study details
- Study details
Official title
CABRIO: Clinical and biological monitoring of children and young adults prior to, during, and after CAR T-cell therapy, a prospective single-center studyCancer type
Acute lymphoblastic leukemia
If CAR T-cell therapy will become available for other types of childhood cancer, the protocol will be amended
Maximum number of patients
60, all in the NetherlandsStart date
September 23, 2025Status
OpenLocal principal investigator
Dr. Friso CalkoenSponsor
Princess Máxima Center for pediatric oncologyApproval
The study of this new treatment has been reviewed by an accredited medical research ethics committee. This committee has decided that it is justified to ask patients to participate in this study. More information can be found at: CCMO.Trial registry number
Research Portal CCMO: ABR NL83405.041.23
The above information is intended as a brief summary only and may not reflect the most up-to-date information. For full details and the current status of a protocol, physicians can contact the Princess Máxima Center directly.