The Horizon 2020 CARAMBA project started in January 2018. The project consortium is researching an innovative immunotherapy for the treatment of multiple myeloma, known as Chimeric Antigen Receptor T-cell therapy (CAR-T). Through strategic collaboration with a wide-range of stakeholders, including Myeloma Patients Europe, the consortium aims to ensure the streamlined transition of CAR-T from the laboratory through to multiple myeloma patients in the clinic.
CARAMBA is specifically looking at targeting CAR-T at a specific protein called SLAMF7 which is expressed on the surface of myeloma cells. The safety and efficacy of SLAMF7 specific CAR-T cells will be assessed in multiple myeloma patients through a small Phase I/II clinical trial involving around 30 patients. In the clinical trial, a type of white blood cell which makes up part of the immune system (T-cells) will be collected from patients and equipped with a chimeric antigen-receptor (CAR). When reintroduced into patients’ bodies, it acts like a sensor boosting the ability of the T-cells to find and destroy myeloma cells. This innovative approach has been developed by Dr Michael Hudecek and Prof Hermann Einsele at University Hospital Würzburg.
Over the coming years, the clinical trial will be opening in four cancer centres in Europe – Würzburg, Pamplona, Milan and Lille. As well as the clinical aspects, the project consortium will also collaborate on regulatory and access issues and on ensuring that patient preferences are utilised in the project.
The European Commission selected the CARAMBA project from more than 100 highly-competitive project proposals and will support it over four years with funding of 6.1 million euros.
Ten partners from six EU-countries are collaborating through the CARAMBA project consortium. It includes four clinical centres of excellence in cancer: University Hospital Würzburg (UKW), Ospedale San Raffaele (Milan), Universidad de Navarra (Pamplona) and the Centre Hospitalier Regional et Universitaire de Lille (Lille).
Further project partners include the patient organisation Myeloma Patients Europe (MPE), the DRK- Blutspendedienst Baden-Württemberg-Hessen (BSD-BRK), the German Federal Institute for Vaccines and Biomedicines (PEI), the biotech companies NBE-Therapeutics (Switzerland) and T-CURX (Germany) as well as the French project management provider ARTTIC S.A.S.
- The myeloma patient perspective on the use of Patient-Reported Outcomes (PROs) in CAR-T clinical trials. Exploring the patient perspective is vital in shaping the landscape of clinical trials, especially in fields like myeloma where novel treatments, such as CAR-T therapy, present promising yet complex challenges. In this MPE report, ´The myeloma Patient Perspective on PROs in CAR-T Clinical Trials,´ you can find the research gathered from myeloma patients who have experienced CAR-T therapy. Through a qualitative analysis, we aim to shed light on the utilisation and effectiveness of Patient-Reported Outcomes (PROs) measures in myeloma CAR-T clinical trials. You can read more about our findings and recommendations in the full report here.
- Patient-based evidence requirements in the regulatory and reimbursement assessment of CAR-T cell therapies in Europe. The present discussion paper details findings and provides recommendations for different stakeholders (European regulators, health technology assessment [HTA] bodies, industry and patient organisations) involved in the development or assessment of CAR-T cell therapies and other innovative therapies in blood cancer on their responsibilities and requirements for gathering patient-based evidence. Read the full report here.
Horizon2020 CARAMBA CAR-T interview series
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 754658.