Named ACHIEVE, the trial will enrol adult AML patients who have either relapsed or are refractory to previous therapies.
It will also have a cohort for myelodysplastic syndrome (MDS) patients.
The trial is anticipated to have a total of 37 subjects.
The initial five trial subjects are considered a ‘safety cohort’, spaced at a gap of two weeks, with a safety review carried out by a monitoring board to validate no drug-associated toxicity issues.
After five patients are dosed, the trial will progress to open enrolment.
The company plans open enrolment for the trial in January and wants to extend its clinical efforts in the US in the first half of next year.
This safety cohort is in accordance with the step-wise clinical trial progress of TCBP, which began from the matching of the donor in the Phase Ib trial to a universal donor model, without HLA matching of the donor to patient.
TC BioPharm CEO Bryan Kobel said: “The launch of our Phase IIb trial is a key milestone in the development of our lead therapeutic, OmnImmune, for patients with AML and for TC BioPharm’s emerging pipeline of ‘off-the-shelf’ gamma-delta T cell therapies.
“This study design includes a five patient safety cohort prior to open enrolment, we expect to complete the safety cohort before the end of 2022.
“The next step in the study is a 19-patient interim review, which will allow TCBP to review dosing and increase dosing to a higher level, should our team deem it necessary for efficacy, or we can elect to maintain our current dosing level of 7×107 or 700 million cells per dose.”
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