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NCT02388828 · ClinicalTrials.gov registry record
CART-meso Long-term Follow-up
A clinical trial, sponsored by University of Pennsylvania.
- Completed
- Registry status
- 10
- Enrollment target
NCT02388828: Completed study, sponsored by University of Pennsylvania.
NCT02388828 is a clinical trial that has completed, run by University of Pennsylvania. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02388828 has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- 10 participants
- Enrollment target
Study Summary
This is a non-therapeutic, long-term follow-up (LTFU) study of subjects who have received retroviral-based gene therapy products in cancer studies. All subjects in this LTFU protocol have received lentiviral modified T cells engineered to express an anti-mesothelin scFv Chimeric Antigen Receptor (CAR). This gene therapy product is called CART-meso. Lentiviruses are a subfamily of retroviruses. This protocol is designed in adherence with the November 2006 Food and Drug Administration (FDA) Guidance for Industry, "Monitoring for Delayed Adverse Events" and "Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors " and involves up to 15 years of monitoring of subjects who have been exposed to retrovirus-mediated gene transfer. Subjects will undergo biannual visits for a blood test evaluating persistence of cells with retroviral vector sequences, chemistry, hematology and tumor markers (as applicable). On annual visits, subjects will further undergo a physical exam and medical history (including concomitant medications and adverse events) with careful attention to features possibly related to retrovirus-induced diseases
Interventions
- BIOLOGICAL lentiviral-based CART meso therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-03 |
| Est. Completion | 2019-07 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02388828
The ClinicalTrials.gov registry entry for NCT02388828 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which lentiviral-based CART meso therapy is the first listed.
NCT02388828 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02388828 about?
NCT02388828 is a clinical study titled "CART-meso Long-term Follow-up". This is a non-therapeutic, long-term follow-up (LTFU) study of subjects who have received retroviral-based gene therapy products in cancer studies. All subjects in this LTFU protocol have received lentiviral modified T cells engineered to express an anti-mesothelin scFv Chimeric Antigen Receptor (CA...
What is the current status of trial NCT02388828?
This trial is currently completed. The enrollment target is 10 participants. The study started on 2015-03. Estimated completion is 2019-07.
What interventions are being tested in trial NCT02388828?
The interventions under investigation include: lentiviral-based CART meso therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT02388828?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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