Use of human cells in testing therapeutic antibody fragments
Research type
Research Study
Full title
Use of human cells in testing therapeutic antibody fragments
IRAS ID
279787
Contact name
Andrew Pierce
Contact email
Sponsor organisation
Crescendo Biologics Ltd
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
Crescendo Biologics is a drug discovery company that develops therapeutic human antibody fragments, also known as Humabodies. As part of the drug discovery, antibody fragments undergo testing for a number of properties including the ability to modulate the biological properties of human immune cells. These properties are highly relevant to their use as therapeutics for cancers and other diseases where there is a significant need from patients for novel therapies that improve outcomes and increase quality of life.
For this project, donor samples are required. These samples will be sourced from external institutions who have obtained the relevant informed consent and that have anonymised the samples. Donors will not be identifiable and donor information does not form part of the data analysis for the project. For blood samples, cells will be purified from these samples and used to identify Humabodies capable of binding to human cells and modulating their function in the desired way. Blood samples will also be used to characterise the biological mechanism of action of these humabodies, the proteins to which they bind and related molecules involved in disease processes. Typically, cells isolated from the blood samples will be incubated with antibody fragments and changes in a number of readouts including proliferation, cytokine release, cell surface marker expression, expression of downstream signalling molecules or cytotoxicity will then be measured. In addition to the acquisition of blood, the following may be procured: purified cell populations such as PBMCs and T-cells; purified cells from bone marrow or cord blood; and banked blood cells from cancer patients. The data generated will support the progression of therapeutic agents through drug discovery towards clinical testing in patients with unmet medical need and will contribute to the understanding of immunotherapy.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
20/EM/0100
Date of REC Opinion
21 Apr 2020
REC opinion
Further Information Favourable Opinion