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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-23

Study Completion Date

2018-01-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

CAR-T Long Term Follow Up (LTFU) Study

NCT02445222

Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program

RECRUITING PHASE3

Gene Therapy Follow-up Protocol for People Previously Enrolled in CAR-T Cell Studies

NCT02473757

Lyphoma, B-Cell Leukemia, B-cell Multiple Myeloma +1 more

ENROLLING_BY_INVITATION

Follow-Up for Study Participants Treated With an Allogeneic CAR T-Cell Product

NCT06925685

Hematologic Malignancies Solid Tumors

ENROLLING_BY_INVITATION

Long-term Follow-up of Participants Treated With Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies

NCT06652633

Hematological Malignancies

RECRUITING PHASE3

Long-term Follow-up Study of Patients Receiving CAR-T Cells

NCT03375619

Chronic Lymphocytic Leukemia Lymphomas Non-Hodgkin's B-Cell Lymphoma, Small Lymphocytic +6 more

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.