LTFU for All Cell and Gene Therapy Studies

Not yet recruiting

• Conditions: Hepatocellular Carcinoma; Prostate Cancer
• Interventions: Biological: AZD5851; Biological: AZD0754

• Registration Number: NCT06194461
• Lead Sponsor: AstraZeneca

Brief 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.

Study Timeline

• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2024-01-05
• Study First Posted: 2024-01-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-05
• Study Start: 2025-09-17
• Primary Completion: 2041-11-29
• Study Completion: 2041-11-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

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

Exclusion Criteria

Not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AZD5851	AZD5851	Follow-up for up to 15 years of subjects who received AZD5851 in study NCT06084884
AZD0754	AZD0754	Follow-up for up to 15 years of subjects who received AZD0754 in study NCT06267729

Primary Outcome Measures

Name	Time	Method
Incidence of specific AEs	Maximum of 15 years post dosing	To determine long-term safety of previous treatment with applicable cell and gene therapy products

Secondary Outcome Measures

Name	Time	Method
Disease progression status and Overall survival	Maximum of 15 years post dosing.	To determine long-term efficacy follow-up after previous treatment with a cell or gene therapy product
Kinetics parameters that indicate persistence (eg, Clast and Tlast)	Maximum of 15 years post dosing	To characterise the long-term persistence of the cell or gene therapy product.

Trial Locations

Locations (1)

Research Site; 🇰🇷 Seoul, Korea, Republic of