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NCT03391791 · ClinicalTrials.gov registry record
Long Term Follow up of Subjects Exposed to Genetically Engineered T Cell Receptors
A clinical trial, sponsored by Adaptimmune.
- Terminated
- Registry status
- 2
- Enrollment target
NCT03391791: Clinical Trial study, sponsored by Adaptimmune.
NCT03391791 is a clinical trial that was terminated before completion, run by Adaptimmune. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03391791 was terminated before completion, sponsored by Adaptimmune.
- TERMINATED
- Registry status
- 2 participants
- Enrollment target
Study Summary
Subjects who previously took part in an Adaptimmune study and received genetically changed T cells (including but not limited to MAGE-A10ᶜ⁷⁹⁶T and MAGE-A4ᶜ¹º³²T) are asked to take part in this long term follow-up study. Subjects will be asked to join this study once they complete the parent interventional study. The purpose of this study is to find out if the genetically changed T cells that subjects received in the parent study have any long-term side effects. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study. For a period of 15 years starting from last administration of the genetically changed T cells, subjects will visit their study doctor for a check-up and to have blood tests to look for any changes that might have happened because of the genetically changed T cells.
Primary Outcome
* New malignancies * New incidence or exacerbation of a pre-existing neurologic disorder * New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder * New incidence of a hematologic disorder * Opportunistic and/or serious infections * Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy
Interventions
- GENETIC Genetically engineered T Cell Receptors
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2018-02-28 |
| Est. Completion | 2018-07-24 |
Why NCT03391791 stopped before completion
NCT03391791 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 2 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Genetically engineered T Cell Receptors is the first listed.
NCT03391791 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03391791 about?
NCT03391791 is a clinical study titled "Long Term Follow up of Subjects Exposed to Genetically Engineered T Cell Receptors". Subjects who previously took part in an Adaptimmune study and received genetically changed T cells (including but not limited to MAGE-A10ᶜ⁷⁹⁶T and MAGE-A4ᶜ¹º³²T) are asked to take part in this long term follow-up study. Subjects will be asked to join this study once they complete the parent interven...
What is the current status of trial NCT03391791?
This trial is currently terminated. The enrollment target is 2 participants. The study started on 2018-02-28. Estimated completion is 2018-07-24.
What interventions are being tested in trial NCT03391791?
The interventions under investigation include: Genetically engineered T Cell Receptors (GENETIC).
Who is sponsoring clinical trial NCT03391791?
This trial is sponsored by Adaptimmune, which has 13 total clinical trials registered on ClinicalTrials.gov.
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