November 14, 2023
Interim results from a small phase 3 clinical trial suggest that in the future, patients receiving kidney transplants may not need to take life-long immunosuppressive drugs, thanks to a novel cellular therapy.
More than 60% of patients who received the investigational single-dose therapy (MDR-101, Medeor Therapeutics) following HLA-matched kidney transplant still did not require immunosuppressive therapy at 2 years, according to data reported at Kidney Week, the annual meeting of the American Society of Nephrology.
“The results of this study have the potential to truly change the trajectory of the treatment for kidney transplants,” Giovanni Ferrara, president and CEO at Medeor, said in a press release. “By combining donor and recipient cells to create mixed chimerism and immune tolerance within the transplant recipient, we are working to alleviate the stress and burden of daily immunosuppressants, thereby improving quality of life and prolonged graft survival. We are buoyed by the study results presented today and look forward to the completion of our study and making MDR-101 the new treatment standard for donor matched kidney transplants.”
The treatment is derived from the kidney donor’s blood (CD34+ and CD3+ cells, specifically) and is intended to induce immune tolerance that is specific to the donor. The goal is to achieve mixed chimerism — a blend of donor and recipient cells — that does not prompt an immune response and organ rejection. It has long been known that patients who received hematopoietic stem cell transplantation to treat leukemia and later received a kidney from the same donor did not develop an immune response. MDR-101 treatment deliberately combines blood and kidney donation.
An additional four patients will complete the trial in less than 6 months and are currently off immunosuppressive drugs. However, three patients required the resumption of immunosuppressive therapy during the trial; one patient withdrew at 6 months.
The researchers also looked at quality of life. Patients who received the treatment had improved scores on the Kidney Disease Quality of Life (KDQOL-36) survey compared with patients who received standard treatment up to 3 years after transplant. In particular, investigators observed improvements in activities of daily living and mental health.