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Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU
NCT06116110 · Miltenyi Biomedicine GmbH
In plain English
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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
About this study
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
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
Study design
Enrollment target: 150 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-05-15
Estimated completion: 2039-12-01
Last updated: 2024-11-20
Interventions
Other: Long-term Follow-Up
Primary outcomes
- • The incidence of serious and non serious adverse events of special interest (Up to 15 years)
Sponsor
Miltenyi Biomedicine GmbH · industry
Contacts & investigators
ContactSadie Swift · contact · clinicaltrials@miltenyi.com · 617-218-0044
ContactParis Jamiel · contact · clinicaltrials@miltenyi.com · 617-218-0044
InvestigatorRemi Kaleta, MD · study_director, Miltenyi Biomedicine GmbH
All locations (5)
Stanford UniversityRecruiting
Stanford, California, United States
Yale UniversityRecruiting
New Haven, Connecticut, United States
University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer CenterNot Yet Recruiting
Baltimore, Maryland, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Froedtert Hospital and the Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States