CART-meso Long-term Follow-up

Completed

• Conditions: Subjects Who Have Received Lentiviral-based CART-meso Therapy
• Interventions: Biological: lentiviral-based CART meso therapy

• Registration Number: NCT02388828
• Lead Sponsor: University of Pennsylvania

Brief 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-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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-10
• Study First Submitted QC: 2015-03-10
• Study First Posted: 2015-03-17
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-16
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects who have received lentiviral-based CARTmeso therapy	lentiviral-based CART meso therapy	-

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	At each visit until study completion, up to 15 years

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States