Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU

NCT ID: NCT06116110

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-15

Study Completion Date

2039-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Non Hodgkin Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Long-term Follow-Up

No intervention

Long-term Follow-Up

Intervention Type OTHER

No intervention

Interventions

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Long-term Follow-Up

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Miltenyi Biomedicine GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Remi Kaleta, MD

Role: STUDY_DIRECTOR

Miltenyi Biomedicine GmbH

Locations

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Stanford University

Stanford, California, United States

Site Status RECRUITING

Yale University

New Haven, Connecticut, United States

Site Status RECRUITING

University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Site Status NOT_YET_RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sadie Swift

Role: CONTACT

617-218-0044

Paris Jamiel

Role: CONTACT

617-218-0044

Facility Contacts

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Christina Tran

Role: primary

Jialing Zhang

Role: primary

Nancy Hardy, MD

Role: primary

Christopher Simmons

Role: primary

Hailey McArthey

Role: primary

Other Identifiers

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M-2023-401

Identifier Type: -

Identifier Source: org_study_id

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