None listed
Conditions
Brief summary
This study aims to evaluate the long-term safety and effectiveness of a treatment called CAR T-cell therapy. As CAR T-cell therapy is a new type of treatment that is still being assessed, we do not yet know the long-term effects of the treatment. By continuing to monitor recipients for up to 16 years after they were treated with CAR T-cell therapy, we aim to gain a deeper understanding of safety and effectiveness – this information might help us to safely treat other New Zealanders in the future.
Interventions
This study aims to evaluate the long-term safety and efficacy of investigational CAR T-cell therapies, by monitoring recipients of this treatment for up to 16 years following administration. Participants will have received at least one dose of CAR T-cell therapy as part of a previous interventional clinical trial sponsored by the Malaghan Institute of Medical Research, and will transition to being followed up as part of this study once the follow-up period of the original study ends, for a total
This study aims to evaluate the long-term safety and efficacy of investigational CAR T-cell therapies, by monitoring recipients of this treatment for up to 16 years following administration. Participants will have received at least one dose of CAR T-cell therapy as part of a previous interventional clinical trial sponsored by the Malaghan Institute of Medical Research, and will transition to being followed up as part of this study once the follow-up period of the original study ends, for a total follow-up duration of 16 years post treatment. Current parent trials include NCT06486051 and NCT04049513. Participants of this long-term extension study must have been enrolled in one of these parent trials and received at least one dose of CAR T-cells to be eligible for enrolment to this study. Additional parent trials may be added in the future, if any new CAR T-cell trials sponsored by the Malaghan Institute are run. There are no direct requirements from participants, instead data will be collected from de-identified copies of international cellular therapies registry records, which participants will already be submitting to as a requirement of the parent trial.
Sponsors
Malaghan Institute of Medical Research
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed written informed consent for the long-term extension study 2. Previous participation in a clinical trial sponsored by the Malaghan Institute of Medical Research in which CAR T-cells were the Investigational Product. 3. Receipt of at least one dose of CAR T-cells.
Exclusion criteria
1. Does not provide signed, written informed consent to participate 2. Did not receive at least one dose of CAR T-cells during a Malaghan Institute of Medical Research-sponsored clinical trial (i.e. withdrew from the trial prior to treatment administration)
Outcome results
None listed