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NCT02592577 · ClinicalTrials.gov registry record · Phase 1
MAGE A10ᶜ⁷⁹⁶T for Advanced NSCLC
A Phase 1 study, sponsored by Adaptimmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT02592577 is a Phase 1 study that has completed, run by Adaptimmune. The registered enrollment target is 28 participants.
The verdict
NCT02592577, a Phase 1 study, has completed, sponsored by Adaptimmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This first time in human study is intended for men and women at least 18 years of age who have advanced lung cancer which has grown or returned after being treated. In particular, it is a study for subjects who have a blood test positive for HLA-A\*02:01 and/or HLA-A\*02:06 and a tumor test positive for MAGE A10 protein expression (protein or gene). This trial is a dose escalation trial that will evaluate 3 doses of transduced cells administered after a lymphodepleting chemotherapy regimen using a 3+3 dose escalation design .The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells. When the MAGE A10ᶜ⁷⁹⁶T cells are available, subjects will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by the T cell infusion. The purpose of this study is to test the safety of genetically changed T cells and find out what effects, if any, they have in subjects with lung cancer. The study will evaluate three different cell dose levels in order to find out the target cell dose. Once the target cell dose is determined, additional subjects will be enrolled to further test the safety and effects at this cell dose. Subjects will be seen frequently by the Study Physician right after receiving their T cells back and up to first 6 months. After that, subjects will be seen every three months. Subjects will be seen every 6 months by their Study Physician for the first 5 years after the T cell infusion. If the T cells are found in the blood at five years, then the subjects will continue to be seen once a year until the T cells are no longer found in the blood for a maximum of 15 years. If the T cells are no longer found in the blood at 5 years, then the subject will be contacted by the Study Physician for the next
Interventions
- BIOLOGICAL Autologous Genetically modified T cells, MAGEA10ᶜ⁷⁹⁶T
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2015-11 |
| Est. Completion | 2021-03-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02592577
The ClinicalTrials.gov registry entry for NCT02592577 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Adaptimmune, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Autologous Genetically modified T cells, MAGEA10ᶜ⁷⁹⁶T is the first listed.
NCT02592577 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02592577 about?
NCT02592577 is a clinical study titled "MAGE A10ᶜ⁷⁹⁶T for Advanced NSCLC". This first time in human study is intended for men and women at least 18 years of age who have advanced lung cancer which has grown or returned after being treated. In particular, it is a study for subjects who have a blood test positive for HLA-A\*02:01 and/or HLA-A\*02:06 and a tumor test positive...
What is the current status of trial NCT02592577?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2015-11. Estimated completion is 2021-03-17.
What interventions are being tested in trial NCT02592577?
The interventions under investigation include: Autologous Genetically modified T cells, MAGEA10ᶜ⁷⁹⁶T (BIOLOGICAL).
Who is sponsoring clinical trial NCT02592577?
This trial is sponsored by Adaptimmune, which has 13 total clinical trials registered on ClinicalTrials.gov.
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