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Long-Term Follow-up Protocol for Subjects Treated with Gene-Modified T cells.
EU CTIS ID: 2023-504201-36-00
What this study is testing
1) Assess the risk of delayed adverse events (AEs) following exposure to GM T cells; 2) Monitor for long-term persistence of GM T cell drug products; 3) Monitor for generation of replication competent lentiviruses (RCL), for lentiviral vector-derived GM T-cell drug products; 4) Assess long-term efficacy following treatment with GM T cells; 5)Describe growth and sexual maturity status for subjects who were aged < 18 years at time of GM T-cell treatment
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1) All adult and pediatric participants who received at least one GM T-cell infusion in a previous Celgene-sponsored or Celgene alliance partner-sponsored study, and have discontinued, or completed the post-treatment follow-up period in the parent treatment study, as applicable.
- 2) Participants (and parental/legal representative, when applicable) must understand and voluntarily sign an Informed Consent Form (ICF)/Informed Assent Form (IAF) prior to any study-related assessments/procedures being conducted.
You likely can't join if
- Not Applicable.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Canada
- United Kingdom
- Switzerland
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Canada; United Kingdom; Switzerland; United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.