Table 2. Hurdles and possible solutions for the clinical translation of CAR T cells
HurdlesPossible solutions
Infrastructure for efficient translation missingSupport for establishing clinical centers that combine basic research, GMP production, and clinical research
CAR T cells are genetically modified organisms (GMOs) in certain EU member states and therefore require a release certificate prior to clinical evaluationFacilitate process by putting together a universal documentation on the GMO characteristic of CAR T cells, which will then be applicable to any CAR T cell product
Different requirements among EU member statesHarmonize requirements between member states. To improve the current situation, the Voluntary Harmonization Procedure (VHP) was established (regulation 536/2014 EC)
Lack of disseminated knowledge/specific guidanceSet up databases for ATMP clinical trials and products as well as technology transfer networks
Preparation of CAR T cell‐specific guidelines
Early contact with national competent authorities or EMA
GMP compliance (high burden of documentation already in early phase of application even for clinical trials driven by academia)A GMP‐specific guideline for ATMPs including provisions for early clinical trial material is currently under development by the Commission in consultation with EMA
Product chain identityDevelop a general identifier encoding for all relevant information for the hospital and manufacturer to circumvent patient–product mismatches
Toxicities in clinical trialsBetter animal models to predict the potential toxicities of CARs