DALY PED (B-cell lymphoma)
Clinical study to determine how safe MB-CART2019.1 is and how well it works in children and adolescents with B-cell lymphoma recurrence.
Recruiting
Who can enter
Children whose B-cell lymphoma has returned (relapsed) or responded inadequately to previous treatment (refractory)
Age: between 6 months and 18 years old
Goal
Goal
The goal of this study is to find out how safe the new medicine, called MB-CART2019.1, is and how well it works for the treatment of relapsed or refractory B-cell lymphoma, and how this new treatment influences the quality of life.
Background
Background
MB-CART2019.1, from now on referred to as the investigational medicine, is a form of immunotherapy. White blood cells (T-cells) are removed from the participant's blood. A small piece of genetic information (a protein called “CAR”) is added in the laboratory. These modified T-cells are now called CAR T-cells.
The CAR T-cells are given back to the participant through an IV-line or through a central line that the participant already has. The CAR T-cells can find and destroy the cancer cells via the “CAR”. The investigational medicine specifically targets B-cell cancer cells.
In order to participate in a study please refer to your/your child’s doctor.
For international patients: please feel welcome to contact our International Patients Office.
Last reviewed
Last reviewed
December 18, 2025
Study details
- Study details
Official title
A single-arm, multi-center, open-label Phase II study to determine the safety and efficacy of MB-CART2019.1 in pediatric subjects with relapsed/refractory (r/r) mature B cell neoplasms who have relapsed after one or more prior therapies, including subjects with primary refractory diseaseCancer type
Relapsed B-cell lymphomaPhase
2Maximum number of patients
31, of whom 2 are expected to participate in the NetherlandsStart date
December 18, 2025Status
OpenLocal principal investigator
Dr. B. J. Vormoor – BürgerSponsor
Miltenyi Biomedicine GmbHApproval
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
EU Clinical Trials: 2023-506348-17-00
ClinialTrials.gov: NCT06508931
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.