Through Velindre Cancer Services (VCS) at the Velindre Cancer Centre (VCC) in Cardiff, the Trust delivers high-quality, compassionate cancer treatment while driving access to innovative, life-extending therapies and treatment – including Advanced Therapy Medicinal Products (ATMPs). The population served spans a wide socioeconomic spectrum, with diverse cancer presentations across solid tumours. Additionally, Velindre also provides some radiotherapy treatments to children, Teenage and Young Adults (TYA) oncology patients through collaborative arrangements with local NHS organisations.

The Trust’s Research Service provides comprehensive oversight of clinical research governance, study set-up, delivery, and monitoring across early phase (including studies delivered through the Experimental Cancer Medicine Centre (ECMC) network), late phase, commercial, and non-commercial oncology trials. Operating in alignment with UK Clinical Trials Regulations and International Council for Harmonisation (ICH) Good Clinical Practice (GCP) standards, it delivers a rigorous oversight model for Trust-sponsored studies and maintains a maturing digital research infrastructure. Research is embedded across disease-site teams through close partnerships with specialist clinical departments and internal and external support services. All clinical research activity is undertaken at VCC, or at partner organisation facilities, ensuring a seamless integration between care delivery and research participation.

Velindre Cancer Centre provides a modern, specialist oncology environment with collocated‑ facilities for systemic therapy, radiotherapy, imaging, and research. Core services include a major outpatient department, a large Systemic Anti-Cancer Therapy (SACT) day unit, and a radiotherapy department using advanced approaches. On-site Magnetic Resonance Imaging (MRI), Computed Tomography (CT) and X-ray imaging – combined with regional access to Positron Emission Tomography – Computed Tomography (PET-CT) – support comprehensive research pathways. A specialist Trials Pharmacy service manages standard, complex, and aseptically prepared investigational products, while collaborations with NHS partners in pathology, serology, genomics, and apheresis underpin high quality‑ ATMP delivery. Emerging digital systems and an experienced multidisciplinary research workforce enable the safe delivery of complex, high risk‑ commercial and non-commercial‑ research interventions, including ATMPs. These capabilities will be further enhanced through expanded clinical and research facilities in the new Velindre Cancer Centre, due to open in 2027.

Velindre has delivered, or is in set‑up for, multiple ATMP-related research trials across a growing range of modalities, including personalised cancer vaccines, cell and immune-modulating therapies, and gene modified‑ or autologous products. Several of these studies are delivered through cross organisational‑ pathways where specialist infrastructure – such as apheresis – is hosted by partner organisations. Velindre’s research experience spans both commercial and non-commercial‑ studies and is supported by a maturing governance pathway that embeds feasibility assessment, risk review, delivery oversight, and regulatory compliance throughout the study lifecycle.

The Trust’s research strength is underpinned by a highly collaborative operating model, most notably through the tri-partite Cardiff Cancer Research Partnership (CCRP), bringing together Velindre University NHS Trust, Cardiff & Vale University Health Board, and Cardiff University. Formerly the Cardiff Cancer Research Hub, this strategic partnership integrates research leadership, facilities, academic expertise, and workforce across the region’s oncology ecosystem. Through CCRP, Velindre benefits from:

  • Co-delivery of early-phase, complex and ATMP studies.
  • Shared governance systems and harmonised operational processes.
  • Access to Cardiff University expertise in immunology, genomics, bioinformatics and cancer biology.
  • Cross-organisational research delivery models, with shared research delivery support.

Alongside CCRP, Velindre works closely with national and UK partners including the ECMC (Cardiff), Wales Cancer Research Centre (WCRC), and Health and Care Research Wales (HCRW). Industry partnerships with pharmaceutical and biotechnology sponsors are well-established, enabling Velindre to contribute to a broad and innovative portfolio of high-impact cancer trials.

Through these collaborations and its expanding ATMP readiness, Velindre continues to strengthen its role as a key site for delivering cutting-edge cancer research in Wales.

Velindre University NHS Trust delivers an expanding portfolio of Advanced Therapy Medicinal Product (ATMP) clinical trials, reflecting the organisation’s growing capability in complex immunotherapy, cell therapy, and gene-modified oncology research. Building on strong collaborative pathways through the Cardiff Cancer Research Partnership (CCRP)—linking Velindre University NHS Trust, Cardiff & Vale University Health Board, and Cardiff University – the Trust is involved in the delivery of early‑phase and translational ATMP studies across solid tumours and haematological malignancies.

Velindre has delivered or is currently in set-up for a range of ATMP and ATMP-adjacent modalities, including:

  • Oncolytic viral therapies in solid tumours – modified viruses designed to selectively infect and destroy cancer cells, while also stimulating the immune system to enhance anti-tumour responses.
  • Gene therapies in solid tumours (BSC1 & BSC2) – gene-modified investigational products that deliver therapeutic genetic material into tumour cells to alter their behaviour, increase treatment sensitivity, or improve immune recognition, handled under appropriate biosafety classifications.
  • TCR cell therapy for haematological cancers, delivered in partnership with Cardiff & Vale UHB through the CCRP – where a patient’s own T cells are engineered to recognise specific cancer targets, expanded, and reinfused to attack malignant cells, with Velindre providing oncology care and trial delivery.
  • Emerging solid tumour cell therapies, developed jointly with Cardiff & Vale UHB haematology colleagues – adapting advanced immune cell platforms (such as engineered T cells or NK cells) traditionally used for blood cancers to treat complex solid tumour indications.

Therapy type

CCRP has delivered gene therapies gene therapy studies across both Velindre Cancer Service (VCS) and CCRP.

Disease area

The ambition is that CCRP delivers solid tumour cell therapies and are working towards an infrastructure to do this in association with Cardiff & Vale University Health Board (CVUHB).

Current and future capability

CCRP has delivered gene therapies at both VCS and CCRP.

CCRP is working toward infrastructure within CVUHB to support solid tumour cell therapies.

A haematology TCR cell therapy trial (cell administration) is currently being set-up, representing the first such delivery for CCRP, with close collaboration with the CVUHB haematology team to build expertise in readiness for future solid tumour pathways.

These ATMP modalities sit alongside Velindre’s wider experience in personalised cancer vaccines, immune-modulating biologics, and radiation-integrated therapy combinations.

Velindre hosts the Welsh Bone Marrow Donor Registry which has JACIE (Joint Accreditation Committee of ISCT & EBMT) certification for Apheresis stem cell collection.

Velindre University NHS Trust does not operate a standalone ATMP approval committee; instead, ATMP studies follow a robust cross-organisational governance pathway.

Gene-modified ATMPs requiring specialist biosafety review are assessed by the Cardiff & Vale University Health Board Gene Modification Safety Committee (GMSC), which provides expert evaluation of genetic modification risks and biosafety classification.

Operational and delivery oversight for ATMP studies is supported by two facilitation groups:

The Velindre University NHS Trust Trials Operational Group, which facilitates/coordinates internal capacity and capability, operational readiness, and cross-departmental input.

The Cardiff & Vale UHB Advanced Therapies Research Oversight Committee, which aligns governance and operational pathways for advanced therapies delivered within Cardiff and Vale University Health Board.