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  • Received zamtocabtagene autoleucel in a North American Miltenyi Biomedicine-sponsored clinical study and have not withdrawn consent to be followed or been deemed lost to follow-up.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

Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
Contact:
Yasmin Adam
Yasmin.Adam2@bannerhealth.com

Stanford University
Stanford, California 94305
Contact:
Christina Tran
ctran13@stanford.edu

Yale University
New Haven, Connecticut 06520
Contact:
Jialing Zhang
jialing.zhang@yale.edu

Robert H Lurie Cancer Center
Chicago, Illinois 60611
Contact:
Chiena Whitt
chiena.whitt@northwestern.edu

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

Dana Farber Cancer Institute
Boston, Massachusetts 02215
Contact:
Christopher Simmons
Christopher_Simmons@DFCI.HARVARD.EDU

Duke University Medical Center - Division of Hematologic Malignancies
Durham, North Carolina 27705
Contact:
Matthew McKinney, MD
Matthew.mckinney@duke.edu

Oregon Health and Science University Knight Cancer Institute
Portland, Oregon 97239
Contact:
Richard Maziarz, MD
maziarzr@ohsu.edu

UT Southwestern Medical Center
Dallas, Texas 75390
Contact:
Farrukh Awan, MD
Farrukh.awan@utsouthwestern.edu

Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Hailey McArthey
hmcarthey@mcw.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.