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Long Term Follow up of Subjects Exposed to Genetically Engineered T Cell Receptors

NCT03391791 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 2

Last updated 2021-01-07

No results posted yet for this 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.

Conditions

  • Solid and Hematological Malignancies

Interventions

GENETIC

Genetically engineered T Cell Receptors

No study drug is administered in this study. Subjects who received lentivirus-mediated genetically engineered T Cell Receptors in a previous trial will be evaluated in this trial for long-term safety and efficacy.

Sponsors & Collaborators

  • Adaptimmune

    lead INDUSTRY

Principal Investigators

  • Marcus Butler, MD · Princess Margaret Cancer Centr

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2018-07-24
Completion
2018-07-24
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03391791 on ClinicalTrials.gov