AAV8 TAb Assay for Eligibility in R131L1265-HEMB-2318 Clinical Trial

• Research type

  Research Study

• Full title

  AAV8 TAb Assay for Eligibility in the R131L1265-HEMB-2318 Clinical Trial

• IRAS ID

  346033

• Contact name

  Gerard Dolan

• Contact email

  gerard.dolan@gstt.nhs.uk

• Sponsor organisation

  ARUP Laboratories

• Duration of Study in the UK

  8 years, 0 months, 1 days

• Research summary

  AAV8 TAb Assay for Eligibility in the R131L1265-HEMB-2318 Clinical Trial is a prospective, interventional clinical performance study. The AAV8 Total Antibody (TAb) Assay is used during screening to aid in the identification of patients eligible for the R131L1265-HEMB-2318 trial. Patients with a "not detected" result may be eligible for the R131L1265-HEMB-2318 trial, while patients with a "detected" result are not eligible for the R131L1265-HEMB-2318 trial.
  The AAV8 TAb Assay functional feature to be tested in the performance study is the ability to detect pre-existing anti-AAV8 antibodies in human serum. The AAV8 TAb Assay clinical performance study is conducted as an integral part of the performance investigations for R131L1265-HEMB-2318. This approach will be taken because the AAV8 TAb Assay is being developed for potential future use as a companion diagnostic in the commercial setting, designed as an aid in the selection of hemophilia B patients for whom REGV131-LNP1265 treatment is being considered. Clinical performance of the AAV8 TAb Assay is directly associated with the clinical performance of REGV131-LNP1265 gene therapy during the R131L1265-HEMB-231 trial.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  24/LO/0666

• Date of REC Opinion

  21 Oct 2024

• REC opinion

  Further Information Favourable Opinion