Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Disease Attributes

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

* Eligibility to participate on this study if enrolled on study 20-532 and received infusion of CARv3-TEAM-E T
* The research study procedures include evaluations and follow up visits: Timepoints of each evaluation and follow up visit- per protocol
* Medical History/Physical Exam
* Blood Test
* Assessment of Disease: CT (Computerized Tomography) scan or PET-CT (Positron Emission Tomography-Computerized Tomography) scans.
* Tumor biopsy.
* Data Collection
* Biobanking

CT (Computerized Tomography) scan or PET-CT (Positron Emission Tomography-Computerized Tomography) scans as per protocol

Disease assessments

Tumor Biopsy

Blood test

William Curry, MD

William T Curry, MD

This is a single site, non-randomized, open-label, long-term safety and efficacy follow-up Phase 1 study for subjects who have been treated with CARv3-TEAM-E T cells in clinical Study DF/HCC IRB #20-532 (the main study), that evaluated the safety and efficacy of CARv3-TEAM-E T cells in subjects with newly diagnosed or recurrent glioblastoma

This is a single site, non-randomized, open-label, long-term safety and efficacy follow-up Phase 1 study for subjects who have been treated with CARv3-TEAM-E T cells in clinical Study DF/HCC IRB #20-532 (the main study), that evaluated the safety and efficacy of CARv3-TEAM-E T cells in subjects with newly diagnosed or recurrent glioblastoma.

CARv3-TEAM-E drug product is defined as autologous T lymphocytes transduced with a CAR lentiviral vector encoding a chimeric antigen receptor targeting human EGFRvIII antigen and a T cell engaging antibody molecule (TEAM) targeting wildtype EGFR. CARv3-TEAM-E T cells are administered in subjects up to six times in main Study #20-532.

No investigational treatment will be administered in this study.

The United States Food and Drug Administration (FDA, 2018) recommend long-term follow-up for subjects treated with gene therapy drug products to monitor for selected adverse events (AEs) and the durability of clinical response.

After the subjects in the parent study has been completed (24 months after CARv3-TEAM-E T cells infusion, or \<24 months after CARv3-TEAM-E infusion if subject discontinues due to disease progression or any other reason), subjects will be asked to participate in a long-term follow-up study.

Long-term Follow-up of Subjects Treated With CARv3-TEAM-E T Cells

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive

PFS is defined as the number of days from the day of CARv3-TEAM-E T cells treatment to the first documented disease progression or date of death, whichever occurs first. Patients who are lost to follow up without a known date of progression or death due to any cause will be censored in the analysis at the date of their last available tumor assessment.

An annual physical exam will be conducted for surveillance of manifestations indicative of oncoretroviral diseases.

ersion 5.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE)

Archiving of samples for potential detection of vector-derived RCL. RCL testing will be monitored at the central RCL lab (Indiana University) by a suitable qPCR assay for detection of the lentiviral vector (VSV-g DNA).

VCN will be performed in DNA from whole blood to monitor for persistence of vector sequence

Response Assessment in Neuro-Oncology Criteria (RANO)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Long-term Follow-up of Subjects Treated With CARv3-TEAM-E T Cells	NCT05024175	Glioblastoma Re... Newly Diagnosed... Recurrent Gliob...	Disease assessm... Tumor Biopsy Blood test	18 Years -	Massachusetts General Hospital
Long-term Follow-up of Subjects Treated With CARv3-TEAM-E T Cells	NCT05024175	Glioblastoma Re... Newly Diagnosed... Recurrent Gliob...	Disease assessm... Tumor Biopsy Blood test	18 Years -	Massachusetts General Hospital
Long-term Follow-up of Subjects Treated With CARv3-TEAM-E T Cells	NCT05024175	Glioblastoma Re... Newly Diagnosed... Recurrent Gliob...	Disease assessm... Tumor Biopsy Blood test	18 Years -	Massachusetts General Hospital

Spots Global Cancer Trial Database for disease assessments