LTFU for All Cell and Gene Therapy Studies (LOCUS)

AstraZeneca

Status: Begins enrollment in 4 months

Conditions: Hepatocellular Carcinoma; Prostate Cancer

Treatments: Biological: AZD5851; Biological: AZD0754

Study type: Observational

Funder types: Industry

Identifiers

NCT06194461

D9341C00001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

64 participants in 2 patient groups

AZD5851

Description:

Follow-up for up to 15 years of subjects who received AZD5851 in study NCT06084884

Treatment:

Biological: AZD5851

AZD0754

Description:

Follow-up for up to 15 years of subjects who received AZD0754 in study NCT06267729

Treatment:

Biological: AZD0754