Long-term follow-up for patients treated with zamtocabtagene autoleucel
A Prospective, Observational, Long-term Follow-up Study for Subjects Who Previously Received Zamtocabtagene Autoleucel in a United States Miltenyi Biomedicine-Sponsored Clinical Study
Miltenyi Biomedicine GmbH · NCT06116110
This study follows patients who have received a specific CAR T-cell therapy for non-Hodgkin lymphoma to see how they do over time and if there are any long-term side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Miltenyi Biomedicine GmbH (industry) |
| Drugs / interventions | CAR-T |
| Locations | 5 sites (Stanford, California and 4 other locations) |
| Trial ID | NCT06116110 on ClinicalTrials.gov |
What this trial studies
This observational study monitors patients who have previously received zamtocabtagene autoleucel, a type of CAR T-cell therapy, for non-Hodgkin lymphoma. Participants will be followed for up to 15 years to assess any long-term adverse events related to the gene therapy, as well as the persistence of CAR T-cells and overall efficacy. The study aims to gather data on delayed adverse events and the safety profile of the treatment over an extended period.
Who should consider this trial
Good fit: Ideal candidates are individuals who have previously received zamtocabtagene autoleucel in a Miltenyi Biomedicine-sponsored clinical study.
Not a fit: Patients who have not received zamtocabtagene autoleucel or are currently undergoing other treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of zamtocabtagene autoleucel for patients with non-Hodgkin lymphoma.
How similar studies have performed: Other studies on CAR T-cell therapies have shown promising results, indicating that long-term follow-up can provide critical data on safety and efficacy.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stanford, California and 4 other locations
- Stanford University — Stanford, California, United States (RECRUITING)
- Yale University — New Haven, Connecticut, United States (RECRUITING)
- University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States (NOT_YET_RECRUITING)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
- Froedtert Hospital and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States (RECRUITING)
Study contacts
- Study coordinator: Sadie Swift
- Email: clinicaltrials@miltenyi.com
- Phone: 617-218-0044
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non Hodgkin Lymphoma, Chimeric antigen receptor, CAR T, CD19, CD20