KCH is a key partner of King’s Health Partners, a leading Academic Health Science Centre. KCH is a highly active research institution with significant expertise in the use of investigational and licensed Advanced Therapy Medicinal Products (ATMPs) which have been transformational in improving survival for patients with blood cancers and many other debilitating chronic diseases. KCH has established an extensive ATMP portfolio and is one of a handful of hospitals in the UK that has the capability to manufacture cell and gene therapy products to Good Manufacturing Practice (GMP) standards for clinical use, with several investigator-led and commercial-collaborative trials due that utilises this in-house manufacturing capability.

The ATMP service at KCH is overseen by the Trust ATMP oversight committee which comprises experts from a range of specialities including haematology, hepatology, intensive care unit, clinical research facility, nursing, quality management and pharmacy. There is additional oversight by the Trust Biological safety committee and it is subject to Trust R&D and Pharmacy governance. Clinical staff (doctors, nurses, pharmacists) are trained to safely deliver complex therapies such as ATMPs and manage their unique side effects. Facilities at KCH where ATMP products can be delivered include the haematology cell therapy ward, the National Institute for Health and Care Research (NIHR) King’s Clinical Research Facility and the liver unit. It has a Medicines and Healthcare products Regulatory Agency (MHRA) and Human Tissue Authority (HTA) accredited GMP manufacturing facility (Cell Therapy Unit) where viral vectors and cell-based therapies, including chimeric antigens receptors -T (CAR-T) cells, are manufactured for clinical trials.

The Pharmacy department at KCH has extensive experience in ATMP trials supported by a consultant Pharmacist in ATMPs. The Pharmacy Aseptic Service has substantial expertise in the preparation of high-risk drugs and investigational medicinal products (IMPs) including cytotoxic monoclonal antibodies and bispecific antibodies, maintaining rigorous quality and safety standards for all final products. KCH has a modular aseptic cleanroom that enables it to prepare a range of drugs for critically ill patients. 

The pharmacy department works very closely with the JACIE (Joint Accreditation Committee of ISCT & EBMT) certified haematology department stem

cell transplant unit for oversight, storage and delivery of cell based ATMPs. To date, KCH has treated over 100 patients with ATMPs across 22 different trials (18 commercial, 2 non-commercial and 2 sponsored trials) benefitting patients locally and from across the UK. 

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Our Clinical Research Facility

ATMP trials successfully delivered at KCH in recent years include allogeneic and autologous CAR-T cells, gamma delta T-cells, regulatory T-cells and tumour vaccines for haematological malignancies, CAR T-Regs for liver transplantation, gene therapy products for hepatocellular carcinoma, hepatitis B, Wilson disease and amyotrophic lateral sclerosis, dendritic cell vaccine for glioblastoma and mesenchymal stromal cells (MSCs) for acute respiratory distress syndrome and paediatric acute liver failure.

A wide range of ATMP trials (mostly commercial with some investigator led) are in the pipeline. These include CAR-T cell trials for autoimmune disease (autoimmune myositis, systemic lupus erythematosus and myasthenia gravis) and blood cancers (myeloma, CNS lymphoma, T-ALL), gene-modified macrophages for liver cirrhosis, gene therapy for cystic fibrosis, stem cell-derived cardiac progenitor cells for cardiac failure and MSCs for psoriasis.

KCH ATMP oversight committee.

KCH Biological safety committee.