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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06194461
Other study ID # D9341C00001
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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 -

Study Design


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
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