Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU

Purpose

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

Conditions

  • Non Hodgkin Lymphoma
  • Refractory Diffuse Large B Cell Lymphoma (DLBCL)
  • Relapsed Diffuse Large B Cell Lymphoma
  • High Grade B-cell Lymphoma
  • Central Nervous System Lymphoma
  • Primary Mediastinal B-cell Lymphoma (PMBCL)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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  • Received zamtocabtagene autoleucel in a North American Miltenyi Biomedicine-sponsored clinical study and have not withdrawn consent to be followed or been deemed lost to follow-up.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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Long-term Follow-Up No intervention
  • Other: Long-term Follow-Up
    No intervention

Recruiting Locations

University of Kansas Cancer Center
Westwood, Kansas 66205
Contact:
Sunil Abhyankar, MD
sabhyankar@kumc.edu

More Details

Status
Recruiting
Sponsor
Miltenyi Biomedicine GmbH

Study Contact

Sadie Swift
617-218-0044
clinicaltrials@miltenyi.com

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.