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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.

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Key information

Conditions

Non Hodgkin Lymphoma Central Nervous System Lymphoma Hemic and Lymphatic Diseases High Grade B-Cell Lymphoma Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Primary Mediastinal B-cell Lymphoma (PMBCL) Refractory Diffuse Large B Cell Lymphoma (DLBCL) Relapsed Diffuse Large B Cell Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

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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  • Received zamtocabtagene autoleucel in a North American Miltenyi Biomedicine-sponsored clinical study and have not withdrawn consent to be followed or been deemed lost to follow-up.
  • 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. Number of subjects with new or recurrence of pre-existing malignancy

    Time frame: Up to 15 years

  2. Number of subjects with new incidence or exacerbation of a pre-existing neurological disorder

    Time frame: Up to 15 years

  3. Number of subjects with new incidence or exacerbation of pre-existing rheumatologic or other autoimmune disorders

    Time frame: Up to 15 years

  4. Number of subjects with new incidence of Grade ≥ 3 hematologic disorders

    Time frame: Up to 15 years

  5. Number of subjects with related AEs, related SAEs, and all AESIs

    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 15 years

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

  3. Objective Response Rate (ORR)

    Time frame: Up to 15 years

    ORR for subjects who did not have progressive disease at their last assessment in the parent study; will be assessed by IRC and Investigator using Lugano 2014 Criteria for DLBCL and SCNSL and using IPCG Criteria (Abrey 2005) for PCNSL

  4. Overall Survival

    Time frame: Up to 15 years

    OS, measured from the date of zamtocabtagene autoleucel infusion to the date of the subject's death or the date the subject is last to known to be alive

  5. To determine the number of subjects who relapse after zamtocabtagene autoleucel infusion during LTFU

    Time frame: Up to 15 years

    Disease relapse: Number of subjects who enter the study as responders and relapse

  6. To assess immune reconstitution based on the recovery of total lymphocytes

    Time frame: Up to 15 years

    Change from baseline in peripheral B cell and lymphocyte levels

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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 North American Miltenyi Biomedicine-Sponsored Clinical Study

Important dates

Study start
2024
Primary completion
2041
Study completion
2041
First posted
Nov 3, 2023
Registry last updated
Aug 5, 2026

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.

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