Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06116110

Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Non Hodgkin Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University, Stanford, California, United States

Loading trial locations.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Long-term Follow-Up

Other

No intervention

Primary outcomes

  1. The incidence of serious and non serious adverse events of special interest

    Time frame: Up to 15 years

    AESIs will be collected

Secondary outcomes

  1. 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

  2. Duration of zamtocabtagene autoleucel persistence

    Time frame: Up to 5 years

    Peripheral blood samples will be collected to test for CAR T cells

  3. Objective response rate

    Time frame: Up to 15 years

    ORR

  4. Overall Survival

    Time frame: Up to 15 years

    OS

Study contacts

Contact information is provided by the study sponsor or research team.

Paris Jamiel

CONTACT

[email protected]

617-218-0044

Sadie Swift

CONTACT

[email protected]

617-218-0044

Sponsors and collaborators

Lead sponsor

Miltenyi Biomedicine GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2039
Study completion
2039
First posted
Nov 3, 2023
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.