GentiBio, Inc. is sponsoring a clinical trial known as POLARIS, which aims to evaluate a cell therapy called GNTI-122 in honeymoon adults. It is created specifically for each participant using their own blood cells. GNTI-122 is administered as a single dose.
GNTI-122 is designed to modify regulatory T cells - immune cells that help prevent the body from attacking its own tissues. By enhancing the function of these cells, the treatment may help protect the remaining beta cells.
The Study
The POLARIS study (NCT06919354) is a 78-week, single-arm, multi-center, Phase 1 trial. Everyone gets the treatment; there is no control group and no blinding. The study is organized into three cohorts. The first two, each with three participants, will receive GNTI-122 alone at a low dose (Cohort 1) and a high dose (Cohort 2), respectively. The third cohort, consisting of 10 participants, will receive a high dose of GNTI-122 in combination with rapamycin.
This study is open to adults between 18 and 45 years old who have been recently diagnosed with T1D (within 120 days of screening). They must test positive for at least one T1D-associated autoantibody, be on insulin therapy, and carry a specific genetic marker called HLA-DRB1*04:01. This treatment uses an IV line to collect blood cells from the person being treated, for the therapy's manufacture.
This trial will primarily be looking at safety issues and measuring how the engineered cells behave in the body, but they will also measure C-peptide, which indicates the body's natural insulin production.
Individuals interested in learning more about the POLARIS clinical trial can contact Kristin M Neff at GentiBio, Inc. The phone number provided is 857-327-5483, and the email address is clinical_ops@GentiBio.com.
The POLARIS study is being conducted at nine locations across the United States:
- Duarte, California: City of Hope Medical Center
- San Diego, California: University of California – San Diego
- San Francisco, California: University of California – San Francisco
- Gainesville, Florida: University of Florida – Gainesville
- Miami, Florida: University of Miami, Diabetes Research Institute
- Boston, Massachusetts: Joslin Diabetes Center
- New York, New York: Icahn School of Medicine at Mount Sinai
- Chapel Hill, North Carolina: University of North Carolina at Chapel Hill (currently recruiting)
- Durham, North Carolina: Duke University (currently recruiting)
Discussion
One unusual aspect of the POLARIS study is its use of rapamycin in combination with GNTI-122. Rapamycin is an immunosuppressant drug that has been used for decades to prevent organ transplant rejection. In this study, it is being tested to see if it can help the modified cells survive longer in the body.
More Information
- ClinicalTrials.gov Registry: https://clinicaltrials.gov/study/NCT06919354
- GentiBio, Inc. (Sponsor): https://gentibio.com/
- GentiBio POLARIS Study Page: https://www.gentibio.com/polaris-study
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 BreakthroughT1D or JDCA news, views, policies or opinions. I sometimes use generative AI ("chatbots") to generate draft blogs, parts of blogs, or drafter alternate wordings for these blogs. I always review every part of every published blog to ensure that it is saying what I want, in the tone that I want, truthfully, and accurately. My kid has type-1 diabetes and has participated in clinical trials, which might be discussed here. I am obese and right on the border of T2D and therefore may be taking drugs for those conditions. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog!
