Coronavirus disease 19 (COVID-19) is provoking the greatest global health crisis of this generation. With no vaccine or specific antiviral treatment available to date, the use of convalescent plasma (CP) from recovered COVID-19 patients has been considered a potential curative strategy. To demonstrate its efficacy and safety, clinical studies are ongoing or planned in various EU Member States. Unfortunately, there lacks a coordinated approach involving a large number of blood establishments (BEs) and clinical centres to harmonise protocols and guidelines, to standardise assays for characterising the potency of the plasma and to validate clinical outcome which will be of great importance to ensure that significant conclusions can be drawn. SUPPORT-E brings together major European BEs with world leading research capabilities with the aim to support high quality clinical and scientific evaluation of COVID-19 CP (CCP) and thereby achieve a consensus on the appropriate use of CCP in the treatment of COVID-19 across EU Member States. Hence, SUPPORT-E will advance the current state-of-the-art by delivering the much needed harmonised evidence-based recommendations with respect to the use of CPP in clinical trials and monitored access programmes for COVID-19 patients in Europe. Further, standardised informative in vitro assays providing scientific insights that could support such recommendations will also be developed. SUPPORT-E offers an EU-wide collaboration between Member States, BEs and clinical centres in order to close the knowledge gap and to ensure applicability of the recommendations for all EU Members States. SUPPORT-E represents the first European Union coordinated research effort on passive immunotherapy, sharing data and protocols in real-time and pooling efforts to decrease the time as much as possible for validating CCP as a valid therapeutic treatment and also providing a basis for further optimisation by combined approaches with other anti-viral treatments.

CARAMBA is proposing to use the revolutionary CAR-T cell technology to tackle multiple myeloma, a rare and incurable hematologic malignancy. Myeloma is associated with a substantial socioeconomic burden and there is a strong demand by patients, their families and caregivers for a curative myeloma treatment. The CARAMBA investigators will conduct a phase I/II clinical trial of immunotherapy with patient-derived T cells that are engineered to express a synthetic chimeric antigen receptor (CAR) specific for the myeloma antigen SLAMF7. SLAMF7 is uniformly expressed on all myeloma cells in every patient, and SLAMF7 CAR-T cells will be equally effective in women and men. The efficacy and safety of SLAMF7 CAR-T cells has been validated by the coordinator in comprehensive pre-clinical testing which highlighted their unprecedented curative potential. SLAMF7 CAR-T cells have received an orphan designation for the indication multiple myeloma by the EC. The successful conduct, rapid and complete recruitment into the clinical trial is ensured by participation of 4 clinical myeloma centres of excellence in 4 EU member states, and the largest myeloma patient advocacy group in Europe, MPE. The SME partners in CARAMBA are prepared to develop the SLAMF7 CAR product all the way to market authorization. CAR-T cell therapy has been recognized as a ‘Breakthrough Therapy’ and clinical proof-of-concept obtained with CD19 CAR-T cells in leukemia and lymphoma. CARAMBA is building on novel and proprietary, cutting-edge CAR technologies including virus-free Sleeping Beauty CAR gene-transfer from DNA minicircles which substantially reduces the cost of CAR-T cell manufacturing, making it an economically viable and sustainable medicinal product. We are confident, that if funded, CARAMBA will accomplish its objective to establish the role of CAR-T cell therapy as a therapeutically effective, commercially attractive and socioeconomically desirable treatment in myeloma and other rare diseases.