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Purpose

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

Conditions

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  • Received zamtocabtagene autoleucel in a North American Miltenyi Biomedicine-sponsored clinical study and have not withdrawn consent to be followed or been deemed lost to follow-up.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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.