Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU
A Prospective, Observational, Long-term Follow-up Study for Subjects Who Previously Received Zamtocabtagene Autoleucel in a United States Miltenyi Biomedicine-Sponsored Clinical Study
1 other identifier
observational
150
1 country
5
Brief Summary
This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2024
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2023
CompletedFirst Posted
Study publicly available on registry
November 3, 2023
CompletedStudy Start
First participant enrolled
May 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2039
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2039
November 20, 2024
November 1, 2024
15.6 years
October 30, 2023
November 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence of serious and non serious adverse events of special interest
AESIs will be collected
Up to 15 years
Secondary Outcomes (4)
Number of subjects with measurable replication competent lentivirus in peripheral blood (if positive at study entry)
Up to 15 years
Duration of zamtocabtagene autoleucel persistence
Up to 5 years
Objective response rate
Up to 15 years
Overall Survival
Up to 15 years
Study Arms (1)
Long-term Follow-Up
No intervention
Interventions
Eligibility Criteria
Patients who have received MB-CART2019.1
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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
Biospecimen
Whole blood and tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Remi Kaleta, MD
Miltenyi Biomedicine GmbH
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2023
First Posted
November 3, 2023
Study Start
May 15, 2024
Primary Completion (Estimated)
December 1, 2039
Study Completion (Estimated)
December 1, 2039
Last Updated
November 20, 2024
Record last verified: 2024-11