CNK-UT009, as tested here, is a one-time infusion of living cells designed to modify the immune system’s behavior. The idea behind it is that by reprogramming T cells, it may be possible to suppress the misdirected immune response that causes type 1 diabetes while potentially allowing remaining beta cells to function better. Animal studies suggest that this method could reduce autoimmunity and improve C-peptide levels.
The company developing this is ST Phi Therapeutics Co., Ltd. (in China) and should not be mixed up with STɸ "ST phi" (in Washington state USA). They are both biotech companies, but otherwise completely different. ST Phi Therapeutics has developed infrastructure (or "a platform", in biotech terminology) called CNK-UT. It is variant of CAR-T genetic engineering, but (they claim) better than CAR-T. See the discussion section for more on CAR-T. They have used their CNK-UT platform to create at least four different specific treatments, of which CNK-UT009 is one. All of these are in early research phases.
The Study
The goals of the study are to evaluate the safety and tolerability of the CNK-UT009 cell injection and to determine the maximum tolerated dose. This will be assessed by monitoring adverse events and the severity of any treatment-emergent adverse events. The primary efficacy endpoint is C-peptide levels. Secondary endpoints include changes in HbA1c levels, continuous glucose monitoring data, average daily insulin dosage, and the level of islet autoantibodies.The trial is single-arm, open-label study, meaning 12 participants (all adults with T1D) will receive the CNK-UT009 cell injection, and there will be no placebo or control group. This trial is open to both people with established T1D and T1D honeymooners.
The study will also examine how long the modified cells stay in the body (pharmacokinetics) and whether participants develop antibodies against the treatment (immunogenicity).
The trial is currently recruiting at Zibo Central Hospital (Zibo, Shandong, China)
For more information, interested participants should contact:
Dr. Xiaoming Pang Email: pxm@sdu.edu.cn Phone: +86-5332361126
Results are not expected until end of 2026.
Discussion
CAR-T is a general term for genetically engineered T-cells (part of the immune system). Since T-cells are part of the immune system which leads to T1D, changing them is a promising method to treat T1D. The US FDA and EU regulators have approved several different CAR-T therapies for cancer, but none yet for autoimmune diseases.
More Information
For those interested in learning more, here are key links:
- Clinical Trial Registration: https://clinicaltrials.gov/study/NCT07051564
- Zibo Central Hospital (trial sponsor): http://www.zbzxyy.com
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!
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