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NCT Number: NCT06194461

LTFU for All Cell and Gene Therapy Studies

Master LTFU study will monitor the long-term safety and tolerability of cell or gene therapy study participants from AstraZeneca for up to 15 years post last cell or gene therapy treatment.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Liver Diseases Liver Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, East Melbourne, Australia

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About this study

This is a multi-centre and multinational basket study that will monitor the long-term safety and tolerability of cell or gene therapies in participants that have taken part in other AstraZeneca cell or gene therapy studies for up to 15 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The participant has received a cell or gene therapy in another AstraZeneca protocol.
  • Provision of signed and dated, written informed consent before any study-specific procedures.

Exclusion criteria

Not applicable

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Treatment and study plan

AZD5851

Biological

Safety follow-up for up to 15 years of subjects who received AZD5851 in study NCT06084884.

AZD0754

Biological

Safety follow-up for up to 15 years of subjects who received AZD0754 in study NCT06267729.

Primary outcomes

  1. Incidence of specific AEs

    Time frame: Maximum of 15 years post dosing

    To determine long-term safety of previous treatment with applicable cell and gene therapy products

Secondary outcomes

  1. Disease progression status and Overall survival

    Time frame: Maximum of 15 years post dosing.

    To determine long-term efficacy follow-up after previous treatment with a cell or gene therapy product

  2. Kinetics parameters that indicate persistence (eg, Clast and Tlast)

    Time frame: Maximum of 15 years post dosing

    To characterise the long-term persistence of the cell or gene therapy product.

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A LOng-term Follow-up Master Protocol for Participants Who Received Cell or Gene Therapies in Other AstraZeneca StUdieS (LOCUS)

Acronym: LOCUS

Important dates

Study start
2025
Primary completion
2041
Study completion
2041
First posted
Jan 8, 2024
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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