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CompletedNCT02666248Updated Jun 22, 2023

Long-term Follow-up of Subjects Exposed to Lentiviral-based CART-EGFRvIII Gene-modified Cellular Therapy Products in Cancer Studies

An observational study in Subjects Entering Into This Protocol Will be Followed for up to 15 Years After Initial CART-EGFRvIII Infusion, sponsored by University of Pennsylvania. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by University of Pennsylvania · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3
Ages
18 Years and older
Sex
All
01

Study summary

This is a non-therapeutic, long-term follow-up (LTFU) study of subjects who have received retroviral-based gene therapy products in cancer studies. All subjects in this LTFU protocol have received lentiviral modified T cells engineered to express an anti-EGFRvIII scFv Chimeric Antigen Receptor (CAR).

Read the detailed description

The primary objective of this study is to monitor adult subjects, who as participants of a clinical trial, received T cells modified by a lentiviral vector encoding a chimeric antigen receptor specific for EGFRvIII, for adverse events that may be associated with lentiviral vector gene transfer such as insertional oncogenesis.

02

Conditions studied

  • Subjects Entering Into This Protocol Will be Followed for up to 15 Years After Initial CART-EGFRvIII Infusion
03

In context

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Subjects who have participated in a lentiviral vector study and have received CART-EGFRvIII cells.

Inclusion criteria

  • Subjects will be enrolled into this destination protocol because they have received CART-EGFRvIII cells that were genetically modified with a lentiviral vector. All subjects who have participated in a lentiviral vector study under IND 15968 and have received CART-EGFRvIII cells will be asked to participate in this protocol.
  • Subjects 18 years of age and older
  • Subjects who have provided informed consent prior to their study participation.

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Number of adverse events

    Time frame: 15 years

07

Study locations

2 sites
  • University of California, San Francisco
    San Francisco, California, United States
  • Abramson Cancer Center of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02666248
Lead sponsor
University of Pennsylvania
Responsible party
Sponsor
First posted
Jan 28, 2016
Start date
May 23, 2016
Primary completion
Jan 27, 2018
Completion
Jan 27, 2018
Last update
Jun 22, 2023

Study contacts

Donald O'Rourke, MD
principal investigator · Abramson Cancer Center at Penn Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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