The aim of TCB-101-001 Phase II/III clinical trial of ImmuniCell® is to generate sufficient clinical outcome data for submission of a marketing authorisation application. This is the first trial in the programme and is designed to evaluate formally the safety and efficacy of TC BioPharm’s proprietary Gamma delta T lymphocyte product (ImmuniCell®) in patients with advanced cancers which are unresponsive or refractory to standard therapies.
This is an adaptive, open-label trial of ImmuniCell® treatment for patients with malignant melanoma, renal cell carcinoma or non-small cell lung cancer.
The trial is designed to identify an optimal, safe dose of autologous Gamma delta T cells for future clinical trials, to identify a response signal from at least one of the cancers under investigation and to confirm the safety and efficacy in the selected target tumour.
This ‘adaptive’ trial comprises of three stages:
The ‘adaptive’ trial design comprises three stages:
Stage-1: Dose-escalation to ensure ImmuniCell® is safe at the appropriate therapeutic dose.
Stage-2: Looking at the effectiveness of ImmuniCell® in patients with non-small cell lung cancer
(NSCLC), renal cell carcinoma (RCC), and melanoma.
Stage-3: Looking at a single tumour type (from the three above) to confirm efficacy prior to product
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