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- Received zamtocabtagene autoleucel in a North American Miltenyi Biomedicine-sponsored clinical study and have not withdrawn consent to be followed or been deemed lost to follow-up.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
| Arm | Description | Assigned Intervention |
|---|---|---|
| Long-term Follow-Up | No intervention |
|
Recruiting Locations
University of Kansas Cancer Center
Westwood, Kansas 66205
Westwood, Kansas 66205
More Details
- Status
- Recruiting
- Sponsor
- Miltenyi Biomedicine GmbH
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.