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NCT06116110 | RECRUITING | Non Hodgkin Lymphoma


Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU
Sponsor:

Miltenyi Biomedicine GmbH

Brief Summary:

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

Condition or disease

Non Hodgkin Lymphoma

Intervention/treatment

Long-term Follow-Up

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 150 participants
Official Title : A Prospective, Observational, Long-term Follow-up Study for Subjects Who Previously Received Zamtocabtagene Autoleucel in a United States Miltenyi Biomedicine-Sponsored Clinical Study
Actual Study Start Date : 2024-05-15
Estimated Primary Completion Date : 2039-12-01
Estimated Study Completion Date : 2039-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU

Location Details

NCT06116110


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

United States, California

Stanford University

Stanford, California, United States, 94305

RECRUITING

United States, Connecticut

Yale University

New Haven, Connecticut, United States, 06520

NOT YET RECRUITING

United States, Maryland

University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States, 21201

RECRUITING

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Wisconsin

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

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