Expired Study
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Philadelphia, Pennsylvania 19104


Purpose:

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-mesothelin scFv Chimeric Antigen Receptor (CAR). This gene therapy product is called CART-meso. Lentiviruses are a subfamily of retroviruses. This protocol is designed in adherence with the November 2006 Food and Drug Administration (FDA) Guidance for Industry, "Monitoring for Delayed Adverse Events" and "Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors " and involves up to 15 years of monitoring of subjects who have been exposed to retrovirus-mediated gene transfer. Subjects will undergo biannual visits for a blood test evaluating persistence of cells with retroviral vector sequences, chemistry, hematology and tumor markers (as applicable). On annual visits, subjects will further undergo a physical exam and medical history (including concomitant medications and adverse events) with careful attention to features possibly related to retrovirus-induced diseases


Criteria:

Inclusion Criteria: - Subjects will be enrolled into this destination protocol because they have received CART-meso cells that were genetically modified with a lentiviral vector. All subjects who have participated in a lentiviral vector study under IND #15882 and have received CART-meso 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: - None


Study is Available At:


Original ID:

UPCC 33514, 821715


NCT ID:

NCT02388828


Secondary ID:

821715


Study Acronym:


Brief Title:

CART-meso Long-term Follow-up


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pennsylvania


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

10


Enrollment Type:

Actual


Overall Contact Information

Official Name:Andrew Haas, MD, PhD
Principal Investigator
University of Pennsylvania

Study Dates

Start Date:March 2015
Completion Date:July 2019
Completion Type:Actual
Primary Completion Date:July 2019
Primary Completion Type:Actual
Verification Date:September 2019
Last Changed Date:September 16, 2019
First Received Date:March 10, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of Adverse Events
Time Frame:At each visit until study completion, up to 15 years
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:lentiviral-based CART meso therapy
Arm Name:Subjects who have received lentiviral-based CARTme

Study Arms

Study Arm Type:Other
Arm Name:Subjects who have received lentiviral-based CARTmeso therapy

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Pennsylvania

Samples and Retentions

Study Population: Subjects who have received lentiviral-based CARTmeso therapy
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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