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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: Completed Phase 1 study, sponsored by Adaptimmune.
NCT02592577 is a Phase 1 study that has completed, run by Adaptimmune. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Determine if treatment with autologous genetically modified T cells, (MAGE A10ᶜ⁷⁹⁶T ) is safe and tolerable through assessment of DLTs, AEs, including SAEs; laboratory assessments, including chemistry, hematology, and coagulation; cardiac and pulmonary assessments, including ECG and troponin.
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 |
What the finished NCT02592577 record still lists
NCT02592577 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which Autologous Genetically modified T cells, MAGEA10ᶜ⁷⁹⁶T is the first listed.
NCT02592577 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02592577's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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