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NCT06116110Recruiting

Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU

Miltenyi Biomedicine GmbH

Start Date

5/15/2024

Completion Date

12/1/2041

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* Received zamtocabtagene autoleucel in a North American Miltenyi Biomedicine-sponsored clinical study and have not withdrawn consent to be followed or been deemed lost to follow-up. * 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 LymphomaRefractory Diffuse Large B Cell Lymphoma (DLBCL)Relapsed Diffuse Large B Cell LymphomaHigh Grade B-cell LymphomaCentral Nervous System LymphomaPrimary Mediastinal B-cell Lymphoma (PMBCL)

Locations

Banner MD Anderson Cancer Center

Gilbert, Arizona 85234

United States

Stanford University

Stanford, California 94305

United States

Yale University

New Haven, Connecticut 06520

United States

Robert H Lurie Cancer Center

Chicago, Illinois 60611

United States

University of Kansas Cancer Center

Westwood, Kansas 66205

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

Duke University Medical Center - Division of Hematologic Malignancies

Durham, North Carolina 27705

United States

Oregon Health and Science University Knight Cancer Institute

Portland, Oregon 97239

United States

UT Southwestern Medical Center

Dallas, Texas 75390

United States

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States