TrialSignal
Clinical trial intelligence report
Phase 1/2, Single-Arm, Open-Label Trial to Evaluate the Safety, Feasibility, and Immunogenicity of Ex Vivo CRISPR-Cas9 Gene-Edited Donor Kidneys (Knockout of HLA-A, HLA-B, and CIITA) in Human Renal Transplant Recipients
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jun 20, 2026
NCT ID
NCT07053462
Status
RECRUITING
Phase
Phase 1/2
Sponsor
AMERICAN ORGAN TRANSPLANT AND CANCER RESEARCH INSTITUTE LLC
Executive brief
Investment-Ready Snapshot
The trial is sponsored by the American Organ Transplant and Cancer Research Institute LLC and aims to evaluate the safety and feasibility of CRISPR-Cas9 gene-edited donor kidneys in renal transplant recipients. This innovative approach targets immunogenicity reduction, which could significantly enhance transplant success rates and reduce reliance on immunosuppressive therapies. The market for kidney transplantation is substantial, with a growing demand for improved outcomes in patients with end-stage renal disease. If successful, this intervention could position the sponsor as a leader in the emerging field of gene-edited organ transplantation, potentially attracting partnerships and investments. However, the trial's location in China may limit immediate market access in Western countries, necessitating careful navigation of regulatory landscapes.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT07053462
Indication
End-Stage Renal Disease
Modality
gene therapy
Target
HLA-A, HLA-B, and CIITA genes involved in immune recognition and graft rejection.
Intervention
Ex Vivo CRISPR-Cas9 Gene Editing of Donor Kidney, Kidney Transplantation with Standard Care
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.