Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU

April 24, 2024 updated by: Miltenyi Biomedicine GmbH

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
    • Connecticut
      • New Haven, Connecticut, United States, 06520
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center
        • Contact:
    • Massachusetts
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital and the Medical College of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who have received MB-CART2019.1

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Long-term Follow-Up
No intervention
Other: Long-term Follow-Up
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of serious and non serious adverse events of special interest
Time Frame: Up to 15 years
AESIs will be collected
Up to 15 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with measurable replication competent lentivirus in peripheral blood (if positive at study entry)
Time Frame: Up to 15 years
Peripheral blood samples may be collected for RCL assessment
Up to 15 years
Duration of zamtocabtagene autoleucel persistence
Time Frame: Up to 5 years
Peripheral blood samples will be collected to test for CAR T cells
Up to 5 years
Objective response rate
Time Frame: Up to 15 years
ORR
Up to 15 years
Overall Survival
Time Frame: Up to 15 years
OS
Up to 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Miltenyi Biomedicine GmbH

Investigators

  • Study Director: Remi Kaleta, MD, Miltenyi Biomedicine GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2024

Primary Completion (Estimated)

December 1, 2039

Study Completion (Estimated)

December 1, 2039

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-2023-401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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