TC Biopharm (Holdings) PLC (NASDAQ: TCBP) (NASDAQ: TCBPW), a UK-based clinical stage biotechnology company, announced on Tuesday that it has dosed its first three patients within its Phase 2b clinical trial of OmnImmune, an allogeneic unmodified cell therapy, intended to treat Acute Myeloid Leukemia (AML).
The trial's initial five subjects are believed to be a 'safety cohort', spaced two weeks apart with safety review by an oversight board to confirm no drug related toxicity issues. After the five subjects have been dosed, the study is to advance to open enrolment.
This safety cohort is in line with TCBP's step-wise clinical trial advancement, moving from donor matching in the Phase 1b to a universal donor model with no HLA matching of donor to patient.
The company's Phase 2B trial is named ACHIEVE and it will enrol adults diagnosed with AML who have either relapsed or are refractory to earlier treatments and a cohort for patients with myelodysplastic syndromes (MDS). The trial is likely to enrol around 37 patients.
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