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Trial Title:
Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU
NCT ID:
NCT06116110
Condition:
Non Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma, Non-Hodgkin
Conditions: Keywords:
Chimeric antigen receptor
CAR T
CD19
CD20
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Long-term Follow-Up
Description:
No intervention
Arm group label:
Long-term Follow-Up
Summary:
This is an observational long-term follow-up (LTFU) study for subjects who previously
received zamtocabtagene autoleucel, known as MB-CART2019.1.
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.
Criteria for eligibility:
Study pop:
Patients who have received MB-CART2019.1
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Stanford University
Address:
City:
Stanford
Zip:
94305
Country:
United States
Contact:
Last name:
Christina Tran
Email:
ctran13@stanford.edu
Facility:
Name:
Yale University
Address:
City:
New Haven
Zip:
06520
Country:
United States
Contact:
Last name:
Jialing Zhang
Email:
jialing.zhang@yale.edu
Facility:
Name:
University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center
Address:
City:
Baltimore
Zip:
21201
Country:
United States
Contact:
Last name:
Nancy Hardy, MD
Email:
nhardy1@umm.edu
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Contact:
Last name:
Christopher Simmons
Email:
Christopher_Simmons@DFCI.HARVARD.EDU
Facility:
Name:
Froedtert Hospital and the Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Contact:
Last name:
Hailey McArthey
Email:
hmcarthey@mcw.edu
Start date:
May 15, 2024
Completion date:
December 1, 2039
Lead sponsor:
Agency:
Miltenyi Biomedicine GmbH
Agency class:
Industry
Source:
Miltenyi Biomedicine GmbH
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06116110
