Non-cancer trials - University of Birmingham

The CRCTU also has a portfolio of non-cancer trials, and these are run through two teams –Drugs, Devices, Diagnostics and Biomarkers (D3B) and Inflammation, Advanced and Cellular Therapy (I-ACT).

The Drugs, Devices, Diagnostics and Biomarkers (D3B) collaborative was established in August 2016 to support design and delivery of high-quality, early phase translational research within Birmingham Health Partners (BHP). D3B is located at the heart of Birmingham’s Institute of Translational Medicine (ITM) with team members derived from Birmingham’s Cancer Research UK Clinical Trials Unit (CRCTU). D3B was created to support development of a research portfolio that aligned with the Government’s strategy for UK Life Sciences; this aims to provide patients with early access to novel treatments.

I-ACT trials cover a range of different disease areas, including some cancer trials. Trials currently on their portfolio include auto-immune liver conditions, Rheumatoid Arthritis, Inflammatory Bowel Disease, melanoma and hepatocellular carcinoma. The team contributes to the design, set up and management of early phase trials that are linked to the Birmingham NIHR Biomedical Research Centre, the Innovate UK funded Midlands and Wales Advanced Therapy Treatment Centre, and the Kennedy Trust funded Arthritis Therapy Acceleration Program.

Drugs, Devices, Diagnostics and Biomarkers (D3B)

ALS Study: A Phase II pilot safety and tolerability study of ILB in patients with Motor Neurone Disease (MND)/Amyotrophic Lateral Sclerosis (ALS)

ADaPT: A prospective, phase II, single centre, cross-sectional, randomised study investigating Dehydroepiandrosterone and its Profile in Trauma

AceticA: Pilot Phase II Randomised Controllled Trial to examine the efficacy and optimal dose of Acetic Acid to treat Colonised Burns Wounds

CDAID: A Phase Ib/IIa, Randomised, Double Blind, Placebo-Controlled Trial to Investigate the Safety, Tolerability and Clinical Activity of Humanised Antibody GSK1070806 in the Treatment of Patients with Moderate-to-Severe Crohn’s

Treat Wolfram: A pivotal, international, randomised, double-blind, phase II efficacy and safety trial of sodium valproate, in paediatric and adult patients with Wolfram syndrome

VITTAL: Viability testing and transplantation of marginal livers. An open label, non-randomised, prospective, single arm phase I trial, using normothermic machine liver perfusion NMLP to test viability and transplantation of marginal livers

Inflammation, Advanced and Cellular Therapy (I-ACT)

BUTEO: Phase II trial investigating the safety and activity of the use of BTT1023, a human monoclonal antibody targeting vascular adhesion protein (VAP-1), in the treatment of patients with primary Sclerosing cholangitis (PSC)

ImmunoTACE: Phase II trial, patients randomised to receive Cyclophosphamide and Chemoembolisation with or without multiple dendritic cell administrations

Merlin: Phase II trial, single infusion of selected Mesenchymal Stromal Cells to patients with primary sclerosing cholangitis or autoimmune hepatitis to investigate safety and activity

Polarise: Phase II multi-disease trial investigating the safety and activity of two administrations of ORBCEL-C™ in the treatment of patients with Primary Sclerosing Cholangitis, Rheumatoid Arthritis, Lupus Nephritis and Crohn’s Disease

Pelican: Feasibility trial looking at repeated administration of p38i enhanced circulating dendritic cell vaccination in patients with melanoma

Spring: Phase I trial in patients with Primary Biliary cholangitis. Patients will be randomised to receive either: Regulatory T cell infusion; Interleukin-2 administration; or Regulatory T cell infusion and Interleukin-2