LTFU for All Cell and Gene Therapy Studies

Prostate Cancer Clinical Trial

— LOCUS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06194461
• Other study ID #: D9341C00001
• Status: Not yet recruiting
• Start date: June 12, 2024
• Est. completion date: November 29, 2041

Study information

• Verified date: March 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: November 29, 2041
• Est. primary completion date: November 29, 2041
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• AZD5851
Safety follow-up for up to 15 years of subjects who received AZD5851 in study NCT06084884.
• AZD0754
Safety follow-up for up to 15 years of subjects who received AZD0754 in study NCT06267729.

Locations

Country	Name	City	State
United States	Research Site	Atlanta	Georgia
United States	Research Site	Columbus	Ohio
United States	Research Site	Duarte	California
United States	Research Site	Hackensack	New Jersey
United States	Research Site	Houston	Texas
United States	Research Site	Jacksonville	Florida
United States	Research Site	New York	New York
United States	Research Site	Orange	California
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Portland	Oregon
United States	Research Site	Rochester	Minnesota
United States	Research Site	San Francisco	California
United States	Research Site	Tampa	Florida
United States	Research Site	Westwood	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of specific AEs	To determine long-term safety of previous treatment with applicable cell and gene therapy products	Maximum of 15 years post dosing
Secondary	Disease progression status and Overall survival	To determine long-term efficacy follow-up after previous treatment with a cell or gene therapy product	Maximum of 15 years post dosing.
Secondary	Kinetics parameters that indicate persistence (eg, Clast and Tlast)	To characterise the long-term persistence of the cell or gene therapy product.	Maximum of 15 years post dosing