Polyclonal T-Regs Start A Phase-II Trial (T-Rex)

T-Rex is a phase-II study of polyclonal T Regulator ("T-Reg") cells.  It is a follow on study to work done at UCSF and in Poland which I've blogged about in the past:
http://cureresearch4type1diabetes.blogspot.com/search/label/Polyclonal%20Tregs

A quick summary of this treatment is as follows: remove one specific type of T regulator cell (called "CD4(+)CD25(+)CD127(lo)") from a person with type-1 diabetes.  Grow them out so you have about 500 times more, and then put them back in the same person.  Since regulatory T cells naturally regulate the body's immune system, and the patient now has more of them, the hope is that they will prevent the autoimmune attack which causes type-1 diabetes.

The Study

This study will enroll 111 people divided into three groups (low dose, high dose, and placebo). Patients must be between 12 and 17 years old and be honeymooners (within 100 days of diagnosis). They will be followed for two years.  The primary endpoint is C-peptide generation (the body making it's own insulin) after one year, while secondary endpoints are A1C, insulin usage, adverse effects, and C-peptide at two years.

The study started recruiting in February 2016 and is expected to finish in March 2020.

In previous studies, the treatment involves two trips to the clinic (the second being an overnight stay), about two weeks apart.

Currently, this study is recruiting in two locations, but they hope to add more in the future:

Fargo, North Dakota, United States, 58122
    Contact: Kathryn McEvoy    701-234-3722    kathryn.mcevoy@sanfordhealth.org
    Contact: Vicki Oberg    701-234-6722    vicki.oberg@sanfordhealth.org
Sioux Falls, South Dakota, United States, 57104
    Contact: Lynn M Bartholow, BA    800-305-5059    Lynn.bartholow@sanfordhealth.org
    Contact: Alycia Brantz    605-328-1369    Alycia.Brantz@sanfordhealth.org

Discussion

This is a study where speed of recruitment is going to directly impact how long the study takes. This study gathers data for 2 years, so all data will be collected 2 years after the last patient is recruited. However, recruiting 111 teenagers from just two (relatively low population) sites, such as Fargo, North Dakota and Sioux Falls, South Dakota is going to take years.   The sooner they can recruit from more places, and especially higher population cities, the sooner they can finish recruiting, and the sooner we can see if this works.

This study is sponsored by Caladrius Biosciences, Inc. in collaboration with Sanford Health (which is different than Stanford University).  Caladrius Biosciences is a small pharma company specializing in bringing cellular therapies to market.

The term "cellular therapy" refers to treatments that use whole cells.  Cellular therapy itself is a broad topic and can include stem cell therapies, cellular transplants, etc.  In this case it refers to cellular "self transplants" where the patient receives cells that originated inside himself, but have been processed (in this case, grown out) outside his body.

The Company's web site: http://www.caladrius.com/product-candidates/clbs03/
More: https://www.sanfordhealth.org/promo/the-sanford-project
http://www.prweb.com/releases/2016/04/prweb13308934.htm
http://bismarcktribune.com/lifestyles/health-med-fit/year-old-west-fargo-girl-among-handful-of-kids-in/article_f098e85f-a3b7-5ad0-83a9-0f949147a04c.html
Newspaper Article: http://www.grandforksherald.com/accent/health/4037848-grand-forks-student-participates-groundbreaking-t-rex-diabetes-study
Clinical Trial Registery: https://clinicaltrials.gov/ct2/show/NCT02691247

The same group of researchers are planning to start a another trial, which will combine Polyclonal Tregs and IL-2.  I'll blog on that trial when it starts recruiting.

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.