CART-meso Long-term Follow-up

NCT ID: NCT02388828

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2019-07-31

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

Conditions

Subjects Who Have Received Lentiviral-based CART-meso Therapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Subjects who have received lentiviral-based CARTmeso therapy

lentiviral-based CART meso therapy

Intervention Type: BIOLOGICAL

Interventions

lentiviral-based CART meso therapy

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Haas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

821715

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 33514, 821715

Identifier Type: -

Identifier Source: org_study_id