OncoMatch/Clinical Trials/NCT07053462
CRISPR-Edited HLA Donor Kidney Transplant to Reduce Rejection Risk
Is NCT07053462 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Ex Vivo CRISPR-Cas9 Gene Editing of Donor Kidney for end-stage renal disease.
Treatment: Ex Vivo CRISPR-Cas9 Gene Editing of Donor Kidney — This clinical trial investigates the transplantation of donor kidneys that have been genetically modified ex vivo using CRISPR-Cas9 genome editing to reduce immunogenicity and transplant rejection. Donor kidney grafts will have key human leukocyte antigen (HLA) genes disrupted - specifically, knockout of HLA class I heavy chains HLA-A and HLA-B, along with disabling HLA class II expression by targeting the CIITA gene (a master regulator of HLA-DR/DQ/DP). Approximately 90 adult end-stage renal disease patients will receive a CRISPR-edited donor kidney transplant. The primary objectives are to assess the safety and feasibility of this novel intervention, while secondary objectives evaluate the reduction in immune responses (immunogenicity), graft function, and the practicality of implementing ex vivo gene-edited organ transplantation in humans. By knocking out major donor HLA molecules, the trial aims to reduce T-cell and antibody-mediated recognition of the graft, potentially lowering rejection rates and reliance on high-dose immunosuppressants. Safety, including any off-target effects or unanticipated immune reactions, will be closely monitored, and transplant outcomes will be tracked for one year post-transplant.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Cannot have received: gene therapy
Patients who have previously received any investigational gene therapy
Cannot have received: experimental transplant treatments
donor-specific tolerance induction or other experimental transplant treatments ongoing
Lab requirements
Kidney function
end-stage renal disease (ESRD) who are candidates for kidney transplantation
end-stage renal disease (ESRD) who are candidates for kidney transplantation
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