UK-based TC BioPharm has commenced a Phase I clinical trial to evaluate a new allogeneic cell therapy TCB002 for the treatment of acute myeloid leukaemia (AML).
TCB002 is developed using activated and expanded gamma delta T cells from healthy donors, who are chosen to ensure that their cells are more effective against tumours compared to the patient’s own cells.
Gamma delta T cells, a subset of lymphocytes, are said to possess innate and adaptive immune properties. They also do not elicit ‘graft versus host’ rejection.
The open-label, single-arm Phase I trial will assess the safety and efficacy of three escalating doses of TCB002 in a total of nine adult relapsed or refractory AML patients who are ineligible or do not want a stem cell transplant.
It will examine the potential curative properties of gamma delta T-cells extracted from a blood-related donor of the patients.
The Phase I trial’s primary outcomes are the incidence of treatment-emergent adverse events and dose-limiting toxicities, while secondary measures include overall survival, the proportion of patients in complete remission, and quality of life.
TC BioPharm chief operating officer Angela Scott said: “Treatment of the first patients with TCB002 represents the culmination of a concerted collective effort from our in-house product development, quality, manufacturing, regulatory and clinical teams, as well as the expert physicians at ÚHKT.
“We are now focused on successful completion of this trial and the progression of our CAR-T products to treat further patient groups with unmet clinical needs as part of our strategic plan of delivering allogeneic CAR-T medicines as mainstream cancer therapies.”
The study is being conducted at the Institute of Hematology and Blood Transfusion (ÚHKT) in Prague, Czech Republic, and is expected to be completed in 2021.