Spots Global Cancer Trial Database for Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU
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Trial Identification
Brief Title: Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU
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
Study ID: NCT06116110
Conditions
Interventions
Study Description
Brief 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Stanford University, Stanford, California, United States
Yale University, New Haven, Connecticut, United States
University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Remi Kaleta, MD
Affiliation: Miltenyi Biomedicine GmbH
Role: STUDY_DIRECTOR
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