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RecruitingObservational

A Prospective, Observational, Long-term Follow-up Study for Subjects Who Previously Received Zamtocabtagene Autoleucel in a United States Miltenyi Biomedicine-Sponsored Clinical Study

NCT ID: NCT06116110Sponsor: Miltenyi Biomedicine GmbHLast updated: 2024-11-20

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.

Arms & interventions

  • OtherLong-term Follow-Up

    No intervention

Outcome measures

Primary

  • The incidence of serious and non serious adverse events of special interest

    AESIs will be collected

    Time frame: Up to 15 years

Secondary

  • Number of subjects with measurable replication competent lentivirus in peripheral blood (if positive at study entry)

    Time frame: Up to 15 years

  • Duration of zamtocabtagene autoleucel persistence

    Time frame: Up to 5 years

  • Objective response rate

    Time frame: Up to 15 years

  • Overall Survival

    Time frame: Up to 15 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (5)

Stanford University

Stanford, California, 94305

Recruiting
Christina Tran · Contact
ctran13@stanford.edu

Yale University

New Haven, Connecticut, 06520

Recruiting
Jialing Zhang · Contact
jialing.zhang@yale.edu

University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201

Not Yet Recruiting
Nancy Hardy, MD · Contact
nhardy1@umm.edu

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting
Christopher Simmons · Contact
Christopher_Simmons@DFCI.HARVARD.EDU

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Recruiting
Hailey McArthey · Contact
hmcarthey@mcw.edu