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NCT06116110Recruiting

Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU

Miltenyi Biomedicine GmbH

Start Date

5/15/2024

Completion Date

12/1/2039

Summary

This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.

Detailed Description

This is a non-therapeutic study design. After successful screening, subjects will be monitored for potential gene therapy-related adverse events for up to 15 years post MB-CART2019.1 infusion. Subjects will be assessed yearly for the occurrence of delayed adverse events (AEs), monitored for replication competent lentivirus (RCL) and assessed for long term efficacy as well as CAR-T persistence.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Received zamtocabtagene autoleucel in a Miltenyi Biomedicine-sponsored clinical study and have either completed the study or have discontinued early from the study. * Provided written informed consent to participate in this study. Exclusion Criteria: * None

Interventions

OTHER

Long-term Follow-Up

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Conditions

Non Hodgkin Lymphoma

Locations

Stanford University

Stanford, California 94305

United States

Yale University

New Haven, Connecticut 06520

United States

University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center

Baltimore, Maryland 21201

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States