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Not Yet RecruitingNCT06194461

LTFU for All Cell and Gene Therapy Studies

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
64 (estimated)
Sponsor
AstraZeneca · Industry
Sex
All
Age
18 Years – 130 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALAZD5851Safety follow-up for up to 15 years of subjects who received AZD5851 in study NCT06084884.
BIOLOGICALAZD0754Safety follow-up for up to 15 years of subjects who received AZD0754 in study NCT06267729.

Timeline

Start date
2025-09-17
Primary completion
2041-11-29
Completion
2041-11-29
First posted
2024-01-08
Last updated
2025-06-27

Locations

25 sites across 4 countries: United States, Australia, Japan, South Korea

Regulatory

Source: ClinicalTrials.gov record NCT06194461. Inclusion in this directory is not an endorsement.