LTFU for All Cell and Gene Therapy Studies (LOCUS)

• ClinicalTrials.gov Identifier: NCT06194461
• Recruitment Status: Not yet recruiting
• First Posted: January 8, 2024
• Last Update Posted: March 25, 2024
• Sponsor: AstraZeneca
• Information provided by (Responsible Party): AstraZeneca

Tracking Information

• First Submitted Date: December 7, 2023
• First Posted Date: January 8, 2024
• Last Update Posted Date: March 25, 2024
• Estimated Study Start Date: June 12, 2024
• Estimated Primary Completion Date: November 29, 2041 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 5, 2024)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 5, 2024)

• 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
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: LTFU for All Cell and Gene Therapy Studies
• Official Title: A LOng-term Follow-up Master Protocol for Participants Who Received Cell or Gene Therapies in Other AstraZeneca StUdieS (LOCUS)
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Whole blood, tissue

• Sampling Method: Non-Probability Sample
• Study Population: Participants who have been treated with Cell/Gene therapy products in AstraZeneca clinical trials.

Condition

• Hepatocellular Carcinoma
• Prostate Cancer

Intervention

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

Study Groups/Cohorts

• AZD5851
  Follow-up for up to 15 years of subjects who received AZD5851 in study NCT06084884
  Intervention: Biological: AZD5851
• AZD0754
  Follow-up for up to 15 years of subjects who received AZD0754 in study NCT06267729
  Intervention: Biological: AZD0754

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: March 22, 2024): 64
• Original Estimated Enrollment (submitted: January 5, 2024): 30
• Estimated Study Completion Date: November 29, 2041
• Estimated Primary Completion Date: November 29, 2041 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

-

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 130 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: AstraZeneca Clinical Study Information Center; 1-877-240-9479; information.center@astrazeneca.com

• Listed Location Countries: United States
• Removed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT06194461
• Other Study ID Numbers: D9341C00001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal

Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
• URL: https://vivli.org/

• Current Responsible Party: AstraZeneca
• Original Responsible Party: Same as current
• Current Study Sponsor: AstraZeneca
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: AstraZeneca
• Verification Date: March 2024