The US Food and Drug Administration (FDA) has granted clearance for TC BioPharm’s investigational new drug (IND) application to begin a Phase IB clinical trial of TCB008 (OmnImmune) in relapse/refractory acute myeloid leukaemia (AML).

The open-label, multicentre ACHIEVE2 trial will analyse the persistence/expansion, safety and initial efficacy of single and multiple intravenous doses of TCB008 in AML or myelodysplastic syndrome patients. 

The trial will have dose escalation and dose expansion portions and will enrol a total of nine subjects.

On meeting the protocol’s stipulated requirements, patients will receive up to three more infusions of TCB008 following the initial dosing, as found suitable by the investigator or designee.

OmnImmune is an allogeneic unmodified cell therapy that consists of activated and expanded gamma delta T-cells. 

The therapy includes GDT cells that have been obtained from healthy donors and are subsequently expanded and activated in scale before purification and formulation for patient dosing.

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By GlobalData

TC BioPharm CEO Bryan Kobel said: “The acceptance of the TCB-008 IND is a significant milestone for TC BioPharm and reflects execution of our strategic plan, which we announced to shareholders in April. 

“TC BioPharm will continue to work towards its primary goal of establishing a better method of treatment for the millions of people around the world suffering blood and bone marrow cancer as we establish TCB008 the standard of care for these patients, with higher quality of life and extended remission of these devastating diseases.”

TC BioPharm also plans to advance the UK ACHIEVE trial in AML and intends to file protocol revision before the end of this year.

This approach aims to bring the dose and other requirements in line with the ACHIEVE2 trial of its lead product.

In September this year, TC BioPharm worked with the Queen Mary University of London (QMUL) in London, UK, to analyse the potential of gamma-delta T cells to treat mucosal infections.