RD13-02 uses specially engineered immune cells designed to remove certain immune cells believed to drive the autoimmune attack that damages insulin-producing beta cells. Researchers hope that by removing these harmful immune cells, the immune system may stop attacking the pancreas and allow remaining beta cells to continue working. This is a CAR-T therapy. CAR-T is a genetic engineering technique which has been generating a lot of excitement recently. A specific type of immune cell (called T cells) are taken from a healthy donor and then genetically engineered in the laboratory to attack a specific target. They are then grown in large quantities and used for treatment.
RD13-02 targets a protein called CD7, which is found on the surface of most T cells and natural killer cells (both of these cells are parts of the immune system). In T1D, some T cells mistakenly attack insulin-producing beta cells in the pancreas. The hope is that RD13-02 will attack these bad T-cells, and have a good impact on T1D. Since these are foreign cells, RD13-02 also carries two engineered inhibitory receptors that help it evade rejection by the host's immune system, as well as other modifications designed to prevent the donor cells from attacking the patient's tissues.
RD13-02 was developed by Nanjing Bioheng Biotech Co., Ltd., a Chinese biotechnology company that operates internationally under the name Imviva Biotechnologies.
This Study
There is a single treatment group of nine people, and no control group, so everyone enrolled receives the RD13-02 infusion. Participants must be between 18 and 40 years old and either be at-risk of T1D (with two measured autoantibodies) or in their honeymoon phase. RD13-02 is given as a single intravenous infusion.
The primary outcomes of the trial focus on safety and preservation of beta cell function via C-peptide levels during a mixed meal tolerance test. C-peptide levels are used to evaluate how well the pancreas continues to produce insulin.
Secondary outcomes examine several aspects of glucose control and disease progression. These include changes in insulin dose requirements, changes in HbA1c, fasting blood glucose levels, and time in range measured by continuous glucose monitoring. Another goal is to measure how long the infused RD13-02 cells persist and multiply inside the body after treatment.
Recruitment started in April 2026, with primary data collection expected to be complete by December 2027 and the study finishing by April 2028.
For those interested in participating or learning more, the study contact is:
Jingjing Jiang, MD, PhD
Zhongshan Hospital, Fudan University, Shanghai, China
Phone: 86-021-64041990
Email: jiang.jingjing@zs-hospital.sh.cn
The trial is being conducted at a single site: Zhongshan Hospital, Fudan University, Shanghai, China.
Discussion
The key issues for all treatments aimed at removing the "bad" T-cells is how selective they are. Do they remove the bad T-cells but leave the good ones. Either extreme, getting rid of too many good T-cells or too few bad ones, will fail. That is why treatments like this one need to be tested.
This is not the first human trial of RD13-02 in T1D. A separate, smaller pilot study (NCT07142161) run directly by Nanjing Bioheng Biotech enrolled three participants with autoimmune T1D. That study has not yet finished, and results have not been published. Also it was very strictly a safety study, with no data gathered on efficiency. However, I assume it informed the design of the current, larger Shanghai trial.
RD13-02 has been tested in blood cancers including these studies:
- NCT06732492: A Phase 1 study of RD13-02 in patients with relapsed or refractory CD7-positive natural killer/T-cell malignancies, planned enrollment of 10 patients, currently recruiting.
- NCT06622694: A Phase 1 study in hematologic malignancies, 15 patients, currently recruiting.
- NCT05716113: Completed Phase 1 study in T-cell acute lymphoblastic leukemia and lymphoblastic lymphoma, 20 patients, results presented at ASH 2024.
More Information
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 kid has type-1 diabetes and has participated 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!
