NCT06116110 · Miltenyi Biomedicine GmbH
Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU
What this study is about
This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.
View original scientific description
This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.
Interventions
OTHER
Long-term Follow-Up
No intervention
Primary outcome measures
Number of subjects with new or recurrence of pre-existing malignancy
Time frame: Up to 15 years
Number of subjects with new incidence or exacerbation of a pre-existing neurological disorder
Time frame: Up to 15 years
Number of subjects with new incidence or exacerbation of pre-existing rheumatologic or other autoimmune disorders
Time frame: Up to 15 years
Number of subjects with new incidence of Grade ≥ 3 hematologic disorders
Time frame: Up to 15 years
Number of subjects with related AEs, related SAEs, and all AESIs
Time frame: Up to 15 years
AESIs will be collected
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Gilbert, Arizona
- Stanford, California
- New Haven, Connecticut
- Chicago, Illinois
- Westwood, Kansas
- Baltimore, Maryland
- Boston, Massachusetts
- Durham, North Carolina
- Portland, Oregon
- Dallas, Texas
- Milwaukee, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 5, 2026 · Source of record for eligibility and locations