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GoCART Coalition at the 6th European CAR T-cell meeting

The 6th European CAR T-Cell Meeting took place in Valencia, Spain, and the GoCART Coalition enjoyed opportunities to connect with others in the CAR T space.

At the T2EVOLVE-GoCART Joint Workshop, Jurgen Kaball presented and shared insights into how different consortia could work together to leverage synergies.

GoCART Call for Research Proposals 2023: announcement of two winning proposals

By RESEARCH // CELLULAR THERAPY & IMMUNOBIOLOGY WORKING PARTY (CTIWP) 

GoCART COALITION

EBMT and EHA released the third call for retrospective research proposals within the Scientific Excellence Work Package of the GoCART Coalition in August.

The aim of the call is to promote the use of existing Registry data and other sources of Real World Data and to strengthen collaborations across stakeholders in the field of CAR T-cell therapies.

The selection committee was composed by Prof Anna Sureda (President of the EBMT), Prof Christian Chabannon (Past Chair EBMT Cellular Therapies and Immunobiology Working Party), Prof Chiara Bonini (Board Member of EHA), Prof Martin Dreyling (Board Member of EHA) and Natacha Bolaños (Chair EBMT Patient Advocacy Committee).

This third call for retrospective research proposals has been very competitive; out of the 10 scientific projects that were presented, two have been selected by the selection committee:

1. The Role of Bridging Therapy before CAR-T Cell Therapy in Diffuse Large B-cell Lymphoma: An Analysis of the Lymphoma Working Party of the EBMT

Philipp Berning1, Michael Oertel2, Imke E. Karsten1, Maud Ngoya3, Anna Ossami Saidy4Anna Sureda5, Hans Theodor Eich2, Georg Lenz1, Bertram Glass4, Norbert Schmitz1

1   Department of Medicine A, Hematology, Oncology and Pneumology, University Hospital Muenster, Muenster, Germany.

2   Department of Radiation Oncology, University Hospital Muenster, Muenster, Germany.

3   European Society for Blood and Marrow Transplantation, Hôpital St. Antoine, Paris, France.

4   Department of Hematology and Stem Cell Transplantation, Helios Clinic, Berlin-Buch, Germany.

5   Hematology Department, Institut Català d’Oncologia Hospitalet, IDIBELL, Universitat de Barcelona, Barcelona, Spain.

Impact of Prior B-Cell-Directed Immunotherapy on the Outcome of CD19 CAR-T cell Therapy in Aggressive B-cell Malignancies

Jan C. Schröder, Lucas Mix, Claudia Lengerke and Wolfgang A. Bethge

Department for Hematology, Oncology, Clinical Immunology and Rheumatology, University Hospital Tübingen, Tübingen, Germany

Big congratulations to the winners! Results of these analyses will certainly advance the field of cellular therapy.

Scientific research on gene and cellular therapies increased substantially over the last years. With Real World Data becoming increasingly available, many scientific questions, from different perspectives, can be explored. GoCART wants to maximise the use of data collected in the central EBMT Registry as well as data available to other stakeholders, and to facilitate further collaboration between stakeholders.

The 10 proposals were evaluated against four criteria: scientific impact, novelty, collaboration across stakeholders and feasibility of the proposal. EBMT will economically support the selected studies by providing dedicated personnel resources – the GoCART study team comprised of a study coordinator, data manager and statisticians – to conduct the studies in a prioritised manner.

There will be more opportunities in the future for interested researchers in the field. Please stay tuned for the next call in 2024!

FDA Reports of Secondary Malignancies Following Chimeric Antigen Receptor (CAR) T Cell Therapies and Relative Risk: an EBMT-EHA-GoCART Coalition Statement

We need to bring your attention to the recent warning disseminated by the Food and Drug Administration (FDA) regarding T-cell lymphomas in patients undergoing Chimeric Antigen Receptor T-cell (CART) therapy (1). Specifically, the FDA warning highlights the potential risks associated with CAR T-cell therapies regarding the development of T-cell lymphomas secondary to a mechanism of CART transgene insertional mutagenesis.

While the warning emphasises necessary vigilance and meticulous monitoring during CAR T-cell therapy, at this stage the European Society for Blood and Marrow Transplantation (EBMT) supports the FDA statement that the therapeutic benefits of CAR T-cell therapies outweigh their potential risks for the approved settings.

Nevertheless, certain key questions remain unanswered, including the precise role of transgene insertional mutagenesis in T-cell malignancy cases post-CART therapy, the current practice of re-typing lineage in secondary lymphoid malignancies for patients treated for B-cell lymphoma, and access to molecular analysis for detecting CART transgenes in T-cell malignancies.

Given the scarcity of data, it is becoming crucial to confirm lymphoma subtypes through biopsy in suspected relapse cases, even when immediate therapeutic implications may not be evident.

In response to these evolving developments, the EBMT is commited to the ongoing evaluation of emerging data. We actively support research and audit initiatives, prioritising the safety and well-being of our patients. In the coming weeks, a specific EBMT Survey will be launched at centre level to collect relevant information related to secondary T-cell malignancies potentially linked to insertional mutagenesis.

The commitment of the EBMT community to collaborative efforts in advancing knowledge and improving patient outcomes is essential. We encourage healthcare professionals, scientists, and researchers to actively collaborate and share insights to enhance the knowledge base and refinement of haematopoietic cellular therapies.

Thank you for your ongoing support and commitment and for prioritising the health and safety of our patients.

References
(1) FDA Investigating Serious Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies. 2023;  Available from: https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-investigating-serious-risk-t-cell-malignancy-following-bcma-directed-or-cd19-directed-autologous

Abstract and case report submissions open for 6th European CAR T-cell Meeting

You can now submit your work for the EBMT-EHA 6th European CAR T-cell Meeting taking place on 15-17 February in Valencia, Spain

Abstract and case report submissions are open until December 4, 2023.

The meeting hosts the 4th Emerging Investigators EHA-EBMT Joint Fellowship Awards in the Field of Cell Therapy and Immunotherapy 2024. Submitters under 40 years old at the time of the submission is sent, can apply for this award and the Scientific Programme Committee will select 3 winners. Winners will receive 10,000 and the opportunity to present their work on Day 1. 

Both physicians and nurses are encouraged to submit their work. See how to submit and browse through the topics list and guidelines on the meeting website below.

The new EBMT Registry is live

The new EBMT Registry was officially launched on the 24th of August 2023. This is a remarkable achievement reflecting several years of dedicated teamwork. This innovative platform replaces ProMISe and Castor, streamlining our data management practices for a more cohesive user experience.

The purpose of the EBMT Registry remains clear: to provide a pool of data to EBMT members to conduct studies, assess epidemiological trends, and ultimately improve patients’ lives. Currently, not all functionalities are present, but we are working hard to successively add additional features. In addition, we will continue migrating the remaining data from the ProMISe database throughout the remainder of 2023 and into 2024. We will keep you updated on all aspects of this process.

It’s important to highlight that terminology updates have been implemented. MED-A is now referred to as the Core Dataset, and while the launch of the Extended Dataset (previously MED-B) is planned for 2024, preparations are well underway.

Guidance to the Implementation and operational management of marketed CAR T-cell therapy – by the GoCART Coalition Pharmacist Working Group

The GoCART Coalition is delighted to announce that its Pharmacist Working Group has published a guidance document on the Implementation and operational management of marketed CAR T-cell therapy.

You can find the article below in Bone Marrow Transplant.

Access the guide >>>