NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Longfellow95,

Thank you for the information!!!

Shame they are not telling us what was the nature of the amendments..

Agreed! That's against their policy.(" Policy and Procedure for Research Summaries" https://www.hra.nhs.uk/documents/285/research-summaries-policy-procedure-v1-0-final-2016.pdf)

Anyway, all amendments received a favourable opinion. Perhaps coincidentally, but the date of the last amendment is around the same time as the change in status of the trial in Germany.

The other thing that comes to mind for a substantial amendment, is change of UK manufacturing site. Around this time, UK DCVaxL manufacture switched from Kings in S.London to CCGTT at the Royal Free in N.London.
We've never known why this switch of manufacturing site occurred, but it may account for one of the listed amendments.

I don't think it may account for one of the listed amendments. Both the study treatment (DCVax-L) and placebo (PBMC) were prepared by Cognate and the Fraunhofer Institute for Cell Therapy together for patients in Europe and not by Kings C.

Both the study treatment (DCVax-L) and placebo (PBMC) were prepared by Cognate BioServices, Inc. for all patients in the US and Canada, and by Cognate and the Fraunhofer Institute for Cell Therapy together for patients in Europe,
during the chemoradiotherapy period before the baseline visit. The production of DCVax-L involved processing the resected tumor tissue into a lysate, and then collection, purification, differentiation, activation and loading of the autologous DCs. In general, approximately 2 g of tumor tissue was needed to produce the full ten doses for the 36-month treatment and follow-up schedule. The vaccine was aliquoted in individual doses and cryopreserved at?<?150 °C [22]. The doses were stored centrally, and shipped individually to the clinical trial sites.

https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1507-6

The very precise study duration is presumably the period in the UK when the study was active. Like elsewhere, the active phase of the trial has been completed for some months, with follow up now restricted to logging ongoing patient event dates.

Agreed. That's about the same period the trial was active in Germany. Anyway, the definition of the end of the trial was always the last visit of the last subject undergoing the trial.