NCT07053462RECRUITINGanonymous

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

Sponsor

Source record

AMERICAN ORGAN TRANSPLANT AND CANCER RESEARCH INSTITUTE LLC

Phase

Source record

Phase 1/2

Modality

AI-normalized

gene therapy

Target

AI-normalized

HLA-A, HLA-B, and CIITA genes involved in immune recognition and graft rejection.

Indication / condition

AI-normalized

End-Stage Renal Disease

Intervention

Source record

Ex Vivo CRISPR-Cas9 Gene Editing of Donor Kidney, Kidney Transplantation with Standard Care

Source & freshness

Source record

NCT ID

NCT07053462

Original source

ClinicalTrials.gov

Source last updated

Jul 08, 2025

Ingested at

Jun 12, 2026

Internal sync

Jun 12, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record

View original source fields

NCT ID

NCT07053462

Title

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

Sponsor

AMERICAN ORGAN TRANSPLANT AND CANCER RESEARCH INSTITUTE LLC

Status

RECRUITING

Phase

Phase 1/2

Condition raw

End-Stage Renal Disease, End Stage Renal Disease on Dialysis, End Stage Renal Disease With Renal Transplant, Kidney Transplant Rejection, Kidney Tumor, Kidney Failure, Kidney Ischemia

Condition normalized

End-Stage Renal Disease, End Stage Renal Disease on Dialysis, End Stage Renal Disease With Renal Transplant, Kidney Transplant Rejection, Kidney Tumor, Kidney Failure, Kidney Ischemia

Modality raw

gene therapy

Modality normalized

gene therapy

Target raw

HLA-A, HLA-B, and CIITA genes involved in immune recognition and graft rejection.

Target normalized

HLA-A, HLA-B, and CIITA genes involved in immune recognition and graft rejection.

Interventions

Ex Vivo CRISPR-Cas9 Gene Editing of Donor Kidney, Kidney Transplantation with Standard Care

Public preview

Source record

The trial, sponsored by the American Organ Transplant and Cancer Research Institute LLC, aims to evaluate the safety and feasibility of CRISPR-Cas9 gene-edited donor kidneys in renal transplant recipients. This innovative approach targets key HLA genes to reduce immunogenicity, potentially transforming kidney transplantation by lowering rejection rates and reliance on immunosuppressants. The market for kidney transplantation is significant, with a growing demand for improved graft survival and reduced complications associated with current immunosuppressive therapies. If successful, this trial could position the sponsor as a leader in the emerging field of gene-edited organ transplantation, attracting interest from investors and partners in the biopharmaceutical sector. However, the trial's geographic limitation to China may impact broader market applicability and scalability.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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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 13, 2026

NCT ID

NCT07053462

Status

RECRUITING

Phase

Phase 1/2

Sponsor

AMERICAN ORGAN TRANSPLANT AND CANCER RESEARCH INSTITUTE LLC

Executive brief

Investment-Ready Snapshot

Source & freshness

Provenance

SourceClinicalTrials.gov

Source updatedJul 08, 2025

Internal syncJun 12, 2026

Model versiontrialsignal-ai-v1

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