Communique of GTTAC meeting of 16 Dec 2019
This Communiqué covers matters considered at the 18th video conference of the Gene Technology Technical Advisory Committee (16 December 2019).
The Peter MacCallum Cancer Centre has applied for a licence to conduct an open label Phase I/II clinical trial to assess the safety, immunogenicity and early clinical efficacy of a GM vaccine platform to generate a patient-specific and tumour-specific therapy.
GTTAC noted key points in the RARMP, including that it did not identify substantive risks associated with the proposed trial. The Committee discussed the exclusion criteria, work practices and control measures proposed for the trial, and agreed the resolutions outlined in this licence.