Avotres's AVT001 Starts A Phase-I Trial

AVT001 is an "autologous dendritic cell therapy" meaning that a person's own dendritic immune cells are taken out, processed in some way, and then put back.  Dendritic cells can be thought of as the immune systems "sensors".  They detect foreign invaders and then communicate that knowledge to other types of immune cells (especially T cells).

This trial flows out of some work done at Columbia University.  Basically, researchers there found a defect in a specific type of immune cell called a HLA-E–restricted CD8+ T cells.  They believe that this defect leads to the immune system attacking the beta cells in the pancreas and causing type-1 diabetes.  The researchers found this defect in many (but not quite all) people with type-1 diabetes, but not in people who did not have the disease.  They also found a way to fix the defect in the immune cells.

The basic technique being tested here is to take out dendritic cells from the patient and treat those cells so that when they are put back into the patient, they (in turn) fix the defect in the HLA-E–restricted CD8+ T cells, which leads to type-1 diabetes.

This Study

The trial will enroll 24 people in two groups, treatment and control.  Everyone will be in their honeymoon (diagnosis within the last year), and everyone will be tested to make sure they have the immune cell defect the researchers are targeting.  The treatment group will get three dendritic cell treatments.  Everyone will be followed for 5 months, and they hope to have primary results by Nov-2020, which is quick for a human trial.  However, they will continue to gather data until June-2022.

There are three primary end points for this trial, and all are safety related.  Two are measures of adverse effects and the third checks for changes in blood chemistry.  They also have three secondary endpoints.  These include C-peptide and A1c numbers, which will give an indication if the treatment is working, and an immune measurement, which will give some insight into the mechanism by which it works.   

They are recruiting at the Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts, USA.  Contact information is:
Jason Gaglia, MD 888-813-8669 T1DTrials@joslin.harvard.edu

Trial Registration: https://www.clinicaltrials.gov/ct2/show/NCT03895996
Trial Site Web Page: https://t1dtrials.org/
Paper describing the basis for this trial: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2947239/
Commentary on that paper: https://www.jci.org/articles/view/44395

Discussion

Although both treatments involve dendritic cells, this research is not related to Dr. Trucco's previous work, which I have blogged about in the past.

This trial is sponsored by Avotes Inc.  However, I can not find any useful information on the company or their technology.  So I'm vague on the details.  As far as I can tell, Avotes does not have a corporate web page, and there are no web pages which describe in any detail what the treatment involves, which is very unusual for a clinical trial.

Joshua Levy

http://cureresearch4type1diabetes.blogspot.com 

publicjoshualevy at gmail dot com

All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.