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NCT02989064 · ClinicalTrials.gov registry record · Phase 1
MAGE-A10ᶜ⁷⁹⁶T for Urothelial Cancer, Melanoma or Head and Neck Cancers
A Phase 1 study, sponsored by Adaptimmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT02989064 is a Phase 1 study that has completed, run by Adaptimmune. The registered enrollment target is 10 participants.
The verdict
NCT02989064, a Phase 1 study, has completed, sponsored by Adaptimmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This Phase 1 study is designed as a cell dose escalation trial in HLA-A\*02:01 and HLA-A\*02:06 subjects with MAGE-A10 positive urothelial, melanoma or head and neck tumors. The study will enroll subjects between the ages of 18 and 75 using a modified 3+3 cell dose escalation design, to evaluate dose limiting toxicities and determine the target cell dose range. Following the dose escalation phase, additional subjects will be enrolled at the target cell dose range to further characterize safety and the effects at this cell dose. 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 undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by 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 urothelial, melanoma or head and neck cancer. Subjects will be seen frequently by the Study Physician after receiving their T cells for the next 6 months. After that, subjects will be seen every 3, 6, or 12 months according to the Schedule of Procedures. All subjects completing or withdrawing from the interventional portion of the study will enter a long term follow-up phase for observation of delayed adverse events and overall survival for 15 years post-infusion.
Interventions
- GENETIC Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2016-10 |
| Est. Completion | 2020-06-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02989064
The ClinicalTrials.gov registry entry for NCT02989064 describes a study currently listed as completed, categorized as Phase 1. 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 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 MAGE A10ᶜ⁷⁹⁶T cells is the first listed.
NCT02989064 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02989064 about?
NCT02989064 is a clinical study titled "MAGE-A10ᶜ⁷⁹⁶T for Urothelial Cancer, Melanoma or Head and Neck Cancers". This Phase 1 study is designed as a cell dose escalation trial in HLA-A\*02:01 and HLA-A\*02:06 subjects with MAGE-A10 positive urothelial, melanoma or head and neck tumors. The study will enroll subjects between the ages of 18 and 75 using a modified 3+3 cell dose escalation design, to evaluate dos...
What is the current status of trial NCT02989064?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2016-10. Estimated completion is 2020-06-04.
What interventions are being tested in trial NCT02989064?
The interventions under investigation include: Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells (GENETIC).
Who is sponsoring clinical trial NCT02989064?
This trial is sponsored by Adaptimmune, which has 13 total clinical trials registered on ClinicalTrials.gov.
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