We conduct and manage our own clinical trials using our in-house team. This reflects our fundamental belief that building a strong relationship with physicians who are directly treating patients will provide faster and more efficient clinical development and better products. These are highly specialized experimental medicines with unique properties.
We take a stepwise approach to clinical trials which ensures patient safety. Moving from unmodified autologous (patient-derived) gamma delta T (GDT) cells to unmodified allogeneic (donor-derived) GDTs and on to CAR-engineered allogeneic GDTs has enabled us to assess the clinical suitability for the most beneficial way to treat patients.
We have adopted a progressive approach to clinical trials, which enables us to explore the therapeutic potential of our co-stim CAR product candidate, whilst working towards an effective treatment for patients in de-risked early studies. Engineered T cells are a new modality which presents vast opportunities for novel medicines. At TC BioPharm, we are working closely with physicians, regulators and other stakeholders to accelerate the provision of these medicines by using novel trial designs.
TCB001 ImmuniCell® Clinical Trial
This trial investigated the safety profile of large numbers of GDT cells derived from patients and was open to certain patients with skin, kidney or lung cancers. The trial is closed and the results will be presented in the future. Registered trial number NCT02459067.
TCB002 OmnImmune® Clinical Trial
This trial uses our unmodified GDT cells derived from healthy donors, in a dose escalation study to establish safety of the allogeneic platform. The trial is now recruiting patients with active relapsed or refractory AML. Registered trial number NCT03790072.