Phase 1b2a Study of Allogeneic Hematopoietic Stem Cell Transplantation and Kidney Transplant From the Same Donor to Avoid Lifelong Immunosuppression

What this Trial Is About

Researchers are evaluating a phase 1b2a trial studying sequential alpha-beta depleted hematopoietic stem cell transplantation HSCT and kidney transplantation KT in patients who need a kidney transplant. The goal is to prevent kidney rejection after transplant without lifelong immunosuppression, reducing the risk of chronic rejection and the need for repeated transplants. This trial is for patients with conditions such as SIOD, FSGS, cystinosis, SLE nephritis, or chronic kidney disease stage 4, among others. Participants will undergo one of two conditioning regimens prior to receiving alpha-beta depleted HSCT from a donor. At least three months after HSCT, if donor myeloid engraftment is confirmed and there are no signs of kidney rejection, patients will receive a living donor kidney transplant from the same donor. Pharmacological immunosuppression used for the kidney transplant will be tapered off by day 90 after the transplant if no rejection occurs. The study begins with a safety evaluation in a small group of patients and may expand based on safety and feasibility. During the study, patients will be closely monitored for donor cell engraftment, kidney function, and any signs of graft-versus-host disease GvHD. Researchers will measure how many patients can stop immunosuppression by 90 days after kidney transplant, kidney function at one year, donor chimerism, and any acute or chronic GvHD. Follow-up will include assessments up to five years post-transplant to observe long-term outcomes such as secondary malignancies. Total participation length may extend up to a decade based on study timelines.

Early Trial of Allogeneic Hematopoietic Stem Cell Transplantation for Patients Who Will Receive a Kidney Transplant From the Same Donor